IA #89-08, 8/13/01, "IMPORT ALERT #89-08, "DWPE OF DEVICES W/O APPROVED PMA'S OR IDE'S AND
OTHER DEVICES NOT EQUIVALENT OR NO 510K" ATTACHMENT REVISED 2/3/08
NOTE: This revision is being issued to revise the alert into the current format and terminology. Changes
are
bracketed by asterisks (***).
TYPE OF
ALERT: *** Detention Without Physical Examination (DWPE) ***
NOTE: This import alert represents the Agency's current guidance to FDA field personnel regarding the
manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on
any
person, and does not operate to bind FDA or the public.
PRODUCT: *** Medical devices (see attachment) ***
PRODUCT
CODE: *** See attachment ***
PROBLEM: Devices are being distributed without a 510(k) or an approved PMA or are not the subject of an
IDE.
PAF: *** AAP (Approvals) ***
***
PAC: 82008 ***
COUNTRY: See Attachment
MANUFACTURER/
SHIPPER
ID: See Attachment
IMPORTER'S
ID: N/A
CHARGE: For Class III device:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device
appears to be a Class III device and does not appear to have in effect an approved application for
premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section
520(g)(1) [Adulteration, Section 501(f)(1)(B)]."
For other devices:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to b
e a
post 1976 device for which a Section 510(k) application has not been determined substantially
equivalent or a 510(k) has not been filed [Misbranding, Section 502(o)]."
OASIS CHARGE
CODE: No PMA
No 510(K)
RECOMMENDING
OFFICE: CDRH, OC (HFZ-323)
REASON FOR
ALERT: *** Devices listed in the attachment have not been determined substantially equivalent or lack
either a 510(k) or a Pre-Market Approval (PMA) for commercial distribution or, alternately, lac
k
an Investigational Device Exemption (IDE). ***
GUIDANCE: Districts may detain without physical examination the devices from the firms identified on the
attachment to this alert.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analy
tical
methodology, contact the Division of Field Science at (301) 827-7605.
PRIORITIZATION
GUIDANCE: N/A
FOI: Purging between ^ ^ is required
KEYWORDS: 510(k), PMA, IDE, Medical devices, devices, Class III devices, Pre-Market Approval
PREPARED
BY: Ted Poplawski, DIOP, 301-443-6553
DATE LOADED
INTO FIARS:
Attachment to Import Alert #89-08 Revised 2/3/08
*** Firms and products recommended for DWPE: ***
Manufacturer Device(s) / Date Added Class
All Countries Little Sentry Junior
Infant Breathing Monitor/73FLS
10/30/00
This product was initially recommended for DWPE based on the actions of one firm that was promoting the produc
t
in the United States (U.S.). CDRH has become aware that other firms may be shipping this device to the U.S. w
ith
the following claims:
"The Little Sentry Junior gives parents and healthcare professionals the opportunity to resuscitate babies who
se
breathing has stopped."
"The Little Sentry Junior Monitors the breathing movements of a baby."
"Should the breathing movements stop for a period exceeding 20 seconds, a loud pulsing alarm accompanied by a
red warning light on the monitor is activated."
These types of claims cause the Little Sentry Junior Infant
Breathing Monitor to be classified as a device.
Firm(s) Product(s)/Code(s)
All Countries Ankle Implant Devices
containing P.T.F.E./
87KXC, 87KMD, 87HSN and/or
87MBK - 11/22/00
This product was initially recommended for DWPE based on the actions of one firm that was promoting the
product(s) in the United States (U.S.). CDRH has become aware that other firms may be shipping these devices
to
the U.S. The product is classified as a device, and is of concern when totally or partially constructed of th
e
following:
C. Polytetrafluoroethylene(a.k.a. P.T.F.E., Teflon or Proplast)
C. Without an approved IDE or PMA, or cleared PMN (510(k).
C. The product lacks safety and effectiveness data for PTFE ankle devices specifically, and historical safet
y
issues with PTFE joint replacement devices.
All Countries OssaTron - Orthopedic III
Extracorporeal Shock Wave
System (Model OSA0120 with
a serial number less than 45-
e.g. "OSA0120 SN *")
76L[][]NS
8/20/01
NOTE: Second-hand devices have been advertised for sale; these devices do not meet the specifications for the
approved device. DWPE is recommended for all OssaTron devices unless consigned to the holder of the PMA
application.
FIRM PRODUCT/PRODUCT CODE CLASS
All Countries B-Safe HIV/AIDS 1 & 2 III
Personal and Private
Screening Device
57YY99, 82----
2/17/05
NOTE: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and ar
e
regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood and provide re
sults
in the home in 3-5 minutes.
The test kits are imported into the U.S. through the mail and may be entered as "samples" or for "personal use
". The
contents may be labeled "for investigational use", for "research use", or "for export only". The test kits co
uld
present a serious hazard to the public health, including possible HIV transmission to partners and delayed acc
ess to
medical care due to misdiagnosed false negative tests. If entries are encountered, contact CBER Import/Export
Team at 301-827-6201, and email ORA HQ DIOP EMPLOYEES.
FIRM PRODUCT/
PRODUCT CODE
ALL FIRMS FROM ALL COUNTRIES Any diagnostic test intended to diagnose:
Avian Influenza
Bird Flu
Pandemic Flu
H5N1; or
novel influenza viruses (or similar) in human specimens,
which are not diagnostic tests for Influenza A and/or B.
83NXD, 83GNX, 83GNT, 83GNW, 83GNS,
83GNR, 83NIA
2/8/08
AUSTRALIA
Australian Light Therapy Seasonal Affective Disorder Device
108 Forrest St. (SAD Lights) (2/4/92) III
Cottesloe, W.A. 6011
Australia
Manufactured in China for: "Oradam" latex facial
^
^ 1/20/95
Medec International MEDEC BioResonance System III
22 Letchworth Centre Ave. 89ISA
Salter Point, Australia 2/2/04
FEI# 3004209984
BAHAMAS
IHT Limited HIV Oral Test
P.O. Box N4361 (aka HIV 1,2 & Subtype O Saliva Test) III
Nassau, Bahamas 82---/10/26/99
FEI# 3002835158
Newco Associates HIV Oral Test
P.O. Box CB12611 (aka HIV 1,2 & Subtype O Saliva Test) III
Nassau, Bahamas 82---/10/26/99
FEI# 3001680610
BRITISH VIRGIN ISLANDS (VG)
World Health Diagnostics, Inc. HIV 2 Blood test kit
P.O. Box 362, Roadtown (a.k.a. HIVTESTINGKIT)
Tortola, VG 82- - - ,57YY99
FEI # 3003016883 5/25/00
Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and ar
e
regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic
test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or l
ess.
The test kits are imported into the U.S. through the mail and may be entered as Asamples@ or for Apersonal use
@.
The contents may be labeled Afor investigational use@, for Aresearch use@, or Afor export only.@ The test kit
s
could present a serious hazard to the public health, including possible HIV transmission to partners and delay
ed
access to medical care due to mis-diagnosed false negative tests. If entries are encountered, contact CBER
Import/Export Team at 301-827-6201.
CANADA (CA)
Angel & Company Angelcare Sound - 12/15/98
P.O. Box 879 & Breathing Frequency
Knowlton, Quebec, Canada Monitor
FEI# 3002528073 Product Code: 73BZQ
ANOGEN
(A Division of Yes Biotech HIV-1 & 2 ELISA
Laboratories, Ltd.) 82[][][], 57YY[]99
7035 Fir Tree Drive, Unit 23 7/10/01
Mississauga, Ontario,
Canada L5S 1V6
FEI #3000972835
3001117636
Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and a
re
regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and
provide results in the home in 15 minutes or less.
The test kits are imported into the U.S. through the mail and may be entered as "samples" or for "personal use
." The
contents may be labeled "for investigational use," for "research use," or "for export only." The test kits co
uld present
a serious hazard to the public health, including possible HIV transmission to partners and delayed access to m
edical
care due to misdiagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at
(301) 827-6201.
Anti Aging Solutions Inc. Revitalite Beautifying II
#5-1 Westside Drive Soft Light Laser
Toronto, Ontario GPI = DE
Canada
FEI# 3004127431
MANUFACTURED BY:
Petra-Electric/Peter Hohlfeldt GMBH & Co. KG
Greisbacherstrasse 6
Burgau, Germany
CFN: 3002552471
SoftLaser International, Inc
Ontario, Canada
^ ^ 7/9/04
FEI #3004604770
NOTE: The Canadian firm was issued a Warning Letter from CDRH on 3/25/2004, warning them to discontinue
marketing these devices in the U.S.
There is currently no evidence these devices are marketed in the U.S. by the manufacturer.
Districts should be aware that although the correct product code for this type of product is 89NHN (Lamp, Non-
Heating, for Adjunctive Use in Pain Therapy) the product has previously been miscoded as 95L 22 (Laser
Products/Laser Product for Non-medical Use).
Aqua Sole Company Ltd. Eye Mask (or Eye Masque)
27 Passmore Avenue, Unit #1
Scarborough, Ontario M1V 4T4
Canada
MID #XOAQUSOL27SCA
A & T Company HIV 1/2 Saliva Test Kit
43 Vanity Crest (aka Easy Home Test or easyhivtest)
Richmond Hill, Ontario Product Code: 82[][][], 57YY99
L4B 4E5 Canada 9/14/00
FEI# 3003109775
Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and a
re
regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and
provide results in the home in 15 minutes or less.
The test kits are imported into the U.S. through the mail and may be entered as "samples" or for "personal use
." The
contents may be labeled "for investigational use," for "research use," or "for export only." The test kits co
uld present
a serious hazard to the public health, including possible HIV transmission to partners and delayed access to m
edical
care due to misdiagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at
(301) 827-6201.
BioChem ImmunoSystems, Inc. BioChem SELECT-HIV Kit
10900 Hamon St. Product Code: 57YY99
Montreal, Quebe 7/27/98 c
Canada
FEI #1000229412
Biotronics Research Corp. Matrix II, Bone Growth Stimulator III
1104-3760 Albert St. 89L--OF, 89L--OE, 76L--YD
Burmaby, B.C. V5C 5Y8 10/28/05
Canada
FEI# 3005249404
SHIPPER
OPED Canada Distribution
344 Townsend Avenue
Burlington, Ontario L7T 2A4
Canada
FEI# 3005242416
Problem: The manufacturer's website ^ ^ and the user manual shipped with the
product states the product "Helps Reduce Inflammation, Assists in the Reduction of Pain and Promotes Fracture
Repair."
Biotronix 2000, Inc. NeedleSafe, all models
2185 Michelin including NX3000, NX2000,
Laval, Quebec NX1000, NX5000 SDS; 80KDB
Canada H7L 4S2 &
FEI# 3002129220 Sharpes Container sold with
Model NX5000 SDS and alone;
80MMK - 8/19/98
THE FOLLOWING FIRM (AND PRODUCTS) WAS NOTED ON THEIR INTERNET WEB SITE OFFERING
FOR SALE VARIOUS UNCLEARED MEDICAL DEVICES TO CITIZENS OF THE UNITED STATES. THE
DEVICES APPEAR TO PREVENT PREGNANCY AND DISEASE TRANSMISSION, WHICH REQUIRE
MARKETING CLEARANCE AND MAY NOT BE LEGALLY MARKETED IN THE UNITED STATES (US)
WITHOUT SUCH CLEARANCE. THE DEVICES ARE CONSIDERED ADULTERATED UNDER SECTION
501(f)(1)(B) AND MISBRANDED UNDER SECTION 502(o) OF THE ACT AND MAY BE IN VIOLATION OF
TITLE 21 OF THE UNITED STATES CODE, SECTION 331(a) AND 331(d).
BIRTHCONTROL.COM LEA SHIELD (BARRIER) 85LLQ
1269 56TH. STREET #18037 ANTYCONDOM 85LTZ
DELTA, BC. CANADA C4L2M4 UNISEX CONDOM 85MEE
FEI# 3002983254 DENTAL DAM Correction 5/2/00
OVU-TRAC
LADYCOMP AND BABYCOMP COMPUTERS
OVES CONTRACEPTIVE CAP
Persona Contraceptive Monitor 85MEE 5/8/01
Class III Device
(OTHER ADDRESSES)
188-3854 Gordon Dr.
Kelowma, BC, Canada
FEI #3001066002
BOX 25006 MPPO
KELOWMA, BC. CANADA
FEI #3001159362
Comptronics Devices Limited Oasis Cranial Electrotherapy Stimulator
9008-51 Avenue (CES)
Edmonton, Alberta 84 JXK
Canada 6/29/00
FEI #3003046588
Fidelity Electronics of Canada (Shipper) 5/6/94
5696 Ambler Drive
Mississauga, Ontario, Canada L4W 2K9
MID# XOFIDELE5696MIS
Health Care Products, Inc. Wipeout Long Life Activated N/A
165 Matheson Blvd. E., Suite 8 Dialdehyde
Mississauga, Ontario, (4/27/93)
Canada L4Z3K2
ID# XOHEACAR165MIS
Health Light, Inc. Seasonal Affective III
P.O. Box 3899 Station C Disorder Device
Hamilton, Ontario L8H 7P2 (SAD Lights)
Canada (2/4/92)
Ind Diagnostics Inc. New Choice Pregnancy III
1629 Fosters Way Test Kits
Delta, British Columbia 75LCX
V3M 6S7 9/26/03
Canada
FEI #3003148151
Repacker/Relabeler:
Unique Design Inc.
5773 Ferrier, Suite 206
Montreal, Quebec
H4P 1N3
Canada
FEI #3003541998
International Biotech Corporation HIV 1/2 Blood Test Kit
#616, 10216-124 Street (aka V-Scan HIV-1 & HIV-2)
Edmonton, Alberta, T5N 4A3, Canada 82[][][], 57Y[][]99
FEI# 3002848449 11/9/99
J.K. Orthomedic, Ltee. LARS (Ligament Advanced
a.k.a. Kirschner Canada Reinforced System)
1755 St. Regis 210 PRODUCT CODE: 87LML
Dollard-des-Ormeaux 10/13/95
Quebec, Canada H9B2M9
Medevice Inc. Bio-Mate Spinal Catheter
5080 Timberlea Blvd. 2/25/93
Unit 11, Mississauga
Ontario, L4W 4M2
Canada
XOMEDINC508OMIS
Mediatronic SA Phytoscan Laser Device II
5c route des jeunes GPI = DE
Geneva 4/20/05
Switzerland
FEI# 3004152702
Medionics International, Inc. QC Transfer Sets
Plant:
114 Anderson Avenue 12/15/92
Markham, Ontario L6E 1A5
Canada
MID# XOMEDINT114MAR
Office:
1271 Denison Street
Suite 4950
Markham, Ontario L3R 4B5
Canada
MID# XOMEDINT4950MAR
Northern Light Thechnologies Seasonal Affective Disorder III
3070 Brabant-Marineau St. Device (SAD Lights)
St. Laurent, Quebec I4S 1K7 (2/4/92)
Canada
Nordion International, Inc. Validose Dosimetry System II
447 March Road 8/17/93
P.O. Box 13500
Kanata, Ontario
Canada K2K 1X8
MID# XONORINT1350KAN
Preferred Medical Products Spinal anesthesia II
3280 Schmon Parkway trays containing
Thorold, Ontario L2V 4Y6 tetracaine hydrochloride
Canada for use in the pediatric
population
ID# XOPREMED3280THO
Continuous Spinal Anethesia III
Trays (non-pediatric)
(3/5/93)
Epi-Spinal Tray-Reorder #2002 III
Epi-Spinal Mini Kit-Reorder #2005 III
(7/30/93)
Seville Marketing Discreet HIV Test III
3017 Mountain Way 82---/10/26/99
P.O. Box 16047
North Vancouver, BC, V7J 2R0
Canada
FEI# 3002764311
Sudor, Inc. Ground Zero,
P.O. Box 383 Ground System and
Collingwood Ontario methods for organisms
Canada L9Y 3Z7 (Ground Zero Grounding Device)
FEI # 3002828315 Product Code 84- - - 10/20/99
* Tri Hawk International Histoacryl Tissue III
1570 Rue Bane Adhesive
Montreal, Quebec, Canada, H4L 4M6 5/11/93
*(Shipper for B. Braun Melsungen AC.)
The One and Only Fashion Decorative Contact Lenses/
Beauty Group Inc. 86H -PK, 86H--QD, 86M--UW
74 Simcoe Road 86M--VN, 86M--WL, 86N--CZ
Kettleby, Ontario 86N--IC, 86L--PL, 86L--PM
Canada LOG 1JO 4/7/06
FEI# 3004859412
Ultrasoft Laboratories Contact Lenses (all types) II
8855 Northbrook Court 2/9/93
Burnaby, British Columbia V5J 5G1
Canada
ID# XCULTLAB8855BUR
ID# XCULTSOF4025BUR
X4 Labs Inc. X4 Penile Corrective Device III
6855 De L'Epp Ave 78L[][]KY
Montreal, Quebec, 78N[][]HU
Canada, H3N 2C7 9/16/08
FEI# 3006891323
Yocan Medical Systems Inc Histoacryl Tissue Adhesive (MAY ALSO BE III
4 Spirea Ct. IDENTIFIED AS BIOLOGICAL GLUE)
Thornill, Ontario, Canada 84KGG
L3T 2W1 79MFI
FEI #1000189357 (NOTE: PRODUCT HAS ALSO BEEN CODED AS
A DRUG UNDER 66V--99)
12/17/98
Globus Media All Medical Devices
9390 Pie IX Blvd GPI=DE, DI, BI, SD
Montreal, Quebec H1Z4EP 2/9/05
Canada
FEI# 3004881304
The firm is known to have shipped and/or marketed the following products in the U.S. Rapid HIV Test Kit, Class
III
device; Rapid Syphilis Test Kit, Class III device; One Step Cassette Style Cocaine Test Kit, Class II device;
One
Step Cassette Style Marijuana (THC) Test Kit, Class II device; One Step Cassette Style Amphetamine Test Kit,
Class II device; Rapid Dengue Fever Test Kit, Class III device; One Step Midstream Style HCG Urine (Home)
Pregnancy Test Kit, Class III device. If districts encounter shipments of any device from the above
shipper/marketing firm, contact DIOP, attn Sammi L. Hadden (301) 827-9632.
CHINA, PEOPLES REPUBLIC
Beijing Toplaser All Devices to the indicated importer
Technology Co., Ltd., GPI=DE
No. 1 Street Wai Guan Xie 10/7/08
An Wai, Chao Yang District,
Beijing, China (Mainland)
FEI# 3005450614
Note: CDRH has indicated DWPE of said products requiring 510k approval only if it is being imported by:
^
^
Beijing Toplaser Technology Co. Ltd. and ^ ^ have no cleared or pending 510k's with
CDRH.
Beijing Wantai Biological HIV 1 & 2 Rapid Test Kit III
Pharmacy Enterprise Co.Ltd. 82- - -
No. 7 Chuangxin Rd. 57Y- - 99
Technique Garden of Changping 2/25/04
Beijing, China
FEI# 3003950825
Biocare Electronics Co., Ltd. BU-908 Electronic Convex
5/F, Taohuaynan High-Tech Innovation Ultrasound Scanner
Park, Baoan, 85LQT, 85LXE, 85MAA, 90LQT
Shenzhen, China 90LXE, 90MAA
FEI# 3004061320 12/8/04
Guanzhou HuaNan Medical Positive/Negative Pressure
Apparatus Co., Ltd. (MFR.) Integrated Computer Control
212 Xingang W. Rd. Augmented Sequential External
Guangzhou, 510300, China Counter-Pulsation Devices
FEI# 3001403711 Prod. Code 89[][][]
2/24/98
Shipper for Guanzhou HuaNan:
Shandong Medicines & Health Products
Import/Export Corp.
16 Baoding Road
Qindao, China
FEI# 3000246908
China National Agricultural Machinery Universal Massage
Shenzhen, China Apparatus
MID #CNCHINATSHE 11/30/94
Chongqing Bashan Instrument Factory TDP Special Electromagnetic
83 Shi Xin Road Therapeutic Apparatus
Chongqing, PRC 630039 80ILY
FEI# 3000983373 8/19/97
Doo Jung H.K. Limited Pap Smear Brushes (may be II
Kwan Lan Town shipped as cosmetic brushes
Tai Wo Village or may be brush head only.
Shenzhen, China 6/8/93
ID#: CNDOOJUNSHEN
(Manufacturer)
Hanson Meditech HIV/AIDS Self Test Kit
Shui Wei Tang, Along Celebrates Area 57YY99, 82[][][]
Lotus Pond Road # 167 02/16/07
Nanchong, Sichuan, China
FEI# 3006114822
(Shipper)
Tang Shuwei Dongti HIV/AIDS Self Test Kit
102 Xiatangxincun 57YY99, 82[][][]
54# Lujing Xilu Yuexiuqu 02/16/07
Guangzhou City, Guangdong, China
FEI# 3005966697
Hsin Ten Health and Wealth Industry (HEFEI) Co. Ltd. 4/24/00
Hot House YS-50 FIR
669 Changjiang West Road Health Builder
Heifei, China 89ILY
FEI #3002989940
The Gatoson Holdings, Ltd Pulse Generator, Pacemaker III
One International Finance Centre Implantable
18th Floor 74DXY
1 Harbour View Street, Central 4/14/03
Hong Kong, China
FEI #3003985965
Shenyang Xinzhen Medical Electronic BFGF-8 Computer Controlled
Instrument Company Weight Reducing Machine
No. 52, North Huanghe St Muscle Stimulator
Shengyang, 84NFO, 89IPF
China 89NGX, 89LPQ
FEI# 3004467572 7/20/05
Shenzhen Carewell Electronics Co. Ultrasound Scanner
5A, Huating 3, Time City 85LQT, 85LXE, 85MAA,
Chuangye Rd., Nanshan 90LQT, 90LXE, 90MAA
Shenzhen, China 518054 85HEM
FEI# 3006406402 11/8/07
Surefine Ningbo Medcare Co. Ltd. Patient Examination Gloves I
Flat J-1, 15/F 80L[][]YY, 80F[][]MC,
No. 165 Baizhang Rd. 80L[][]ZC, 80L[][]YZ
Ningbo, China 9/23/05
FEI# 3005066582
CZECH REPUBLIC
***Shipper:
Kamedico Health Care Products, Inc.
1759 West 3rd Avenue
Vancouver, B.C., Canada V6J 1K7
FEI# 1000371924
MID# XCKAMHEA1759VAN
***Be aware that the U.S. manufacturer of the DILAPAN cervical
dilators is ^ ^ who
is presently under injunction since these devices were
manufactured in the absence of a valid supplemental PMA and
contrary to applicable good manufacturing practices (GMPs).***
DENMARK
Ambu International A/S Ambu Cariopump ACD Resuscitator
SDR. Ringvej 49 4/29/94
2600 Glostrup
Denmark
MID #DKAMBINT215GLO
Danamedic Aps Jes-Extender III
Bostamose Oesterstraede 1a (penis extending device)
Klampenborg 78L--KY
Denmark 78N--HU
FEI #3005401991 12/18/06
FINLAND
Labsystems OY Tetanus IgG EIA Kit II
Pulttitie 8
P.O. Box 8
00880 Helsinki, Finland
ID#: FILABOY8HEL
(6/4/93)
FRANCE
Burnet Laboratoire Sterile Surgical Gloves III
Pharmaceutique
Av. Georges Denos, B.P. 61
72403 La Ferte Bernard, France
Chauvin Opsia S.A. Oxane, Purified Silcone Oil III
Rue Max Planck Bp 711 (Intraocular Fluid for Retinal
31683, Labege, France Reattachment)/86LWL
FEI #3002558775 5/31/01
ELA Medical Chorus RM cardia pacemaker model 7034 III
98-100 Rue Maurice Arnoux (9/9/92)
92120 Montrouge, France Chorus II cardia pacemaker Model 6234 III
(9/9/92)
Laboratoires Eurosilicone All Devices III
21, rue Francis Combe 12/28/94
95000 Cergy Pontoise
France
MID# FRLABEUR21PON
Laboratory Nycomed Polyvinyl Alcohol Foam III
Ingenor SA, 25 Quai Particles PVA Foam) and
de la Gare-C.E. Balloon Catheters
No.19
F-75644 Paris Cedex 13
France
LARS LARS (Ligament Advanced
5 Rue de La Fontaine Reinforced System)
Arc Surtille PRODUCT CODE: 87LML
France 21560 10/13/95
Medical Z, S.A. All Scar Management
BP 39, 55, Rue De L'Eglise Gel Products (Medigel Z)
61110 Remalard 79MDA
France 11/27/96
FEI #1000656612
MID #FRMEDSA55REM
Opsia Laboratories All 100% Perflourodecalin III
10, Avenue De L'Europe DK Lines
Ramonville-Saint-Agne
France
Orthomed Ligastic artificial
256 Rue Vignes Dardelain ligament(s)
21160 Marsannay LaCote PRODUCT CODE: 87LML
Dijon, France 10/13/95
ProCytech S.A.S. Outline Ultra III
4 Rue Jacques Monod A Bioresorbable Polyacrylamide
Technopole Montesquieu Filler for Soft Tissue
Martillace, France F-33650 (Facial Augmentation)
FEI # 3003417752 8/26/03
SAPP
#4 Rue Cozette Audiokinetron Device
8000 Amiens Product code 76MGE
France (3/29/94)
MID #FRSAP4AMI
TH SA Presso Dren 207: Pressure Therapy Apparatus
32, Chemin de la 89HTM
Violette 8/2/01
31240 L'Union
France
FEI #3003338887
Tomatis Electronics Electronic Ear, or any device
56 Rue Des Batignolles labeled or marked for auditory
75017 Paris training, auditory integration,
France or behavioral improvement.
FEI #3000190157 2/5/97
MID #FRTOMELE76PAR
AND PRODUCT CODE 84GWJ
Tomatis International 2/5/97
6, Place de la Republique -
Dominicaine
75017 Paris
France
FEI #3000190169
MID #FRTOMINT6PAR
GERMANY
Aesculap Aktiengesellscraft Heifetz Skull Perforator Drill (only) III
Postfach 40 (11/5/92)
D-7200 Tuttlingen, Germany
ALMO-Erzeugnisse Erwin Piston Syringes II
Busch, GmbH 80FMF Lacks 510(k)
34454 Bad Aroisen 8/16/06
Deutschland, Germany
FEI #6064
B. Braun Melsungen AC. Histoacryl Tissue III
Carl Braun Strasse 1 Adhesive
Melsungen, West Germany
ID# DEBRAMEL1MEL
*Beltex Histoacryl Tissue III
C.P. 222 Adhesive
St. Sulpice, Quebec, J6K 3JO (5/11/93)
ID# XQBEL222STS
*(Shipper for B. Braun Melsungen AC.)
(HEADQUARTERS)
Binder International Ondamed System Regulation Lack of 510(k)
GmbH & Co. (Biofeedback Device) Approval
Otto Hahn Strasse 19 84HCC
Herrenberg-Kuppingen 04/29/03
Germany
FEI #3003752197
Binder GmbH
P.O. Box 102
Tuttlingen
Germany
FEI #3003765734
Binder GmbH
Kurzeller Str. 18
Schwanau, AL
Germany
FEI #3003775444
Kendall Germany CURITY Continuous III
CDK Holding GmBH Spinal Anesthesia
Raffineriestr, 8 Tray
COSPAN Continuous III
Spinal Anesthesia
Tray
COSPAN Pediatric III
Spinal Anesthesia
Tray
CURITY Pediatric III
Continuous Spinal
Anesthesia Tray
Leibinger GMBH Total Joint or Condylar protheses for III
Schutzenstrabe 5-7 the Temporomandibular joint (TMJ)
D7200 Tuttlingen (4/16/93)
Germany, Federal Rep. of
ID# DELEIGMB57TUT
U.S. Distributor:^
^
Morcher Gmbh Aniridia Implant III
Kapuzinerweg (i.e. modified Intraocular lenses
D70374 Stuttgart or capsular tension rings)/86MRJ
Wurttemberg-Baden 5/31/01
Fed Rep of Germany
FEI #1000447964
Capsular Tension Rings (only those III
manufactured prior to 12/11/03)
86MRJ
Aniridia Implant Devices III
(Modified Intraocular Lenses)
86HQL
2/9/04
Novafon Elektromedizinche Therapeutic Massagers: Gerate GmbH
(aka Novafon GmbH) Novafon SK1 Sound
Stuttgart, W. Germany Wave Appliance III
ID# DENOVELE7000STU Nostrafon SK2 Sound III
or DENOVGMB7000STU Wave Appliance
Medi-pol, (magnetic field III
therapy attachment used as
an accessory device with
Nostrafon unit)
Rheinmagnet, Inc. Magnetic Devices
Germany No classification name,
FEI #1000490604 number, or regulation citation
MID #DERHEINCUNK 2/29/96
Stihler Electronics GmbH Astoflo Plus II
Julius-Holder Strasse 36 81B[][]SB Lack of 510(K)
D-70597 Stuttgart, Germany 8/4/08
FEI# 3001733054
1000358754
Team Ver Packung Silicone Oil III
Muhlen Koppel 2 for Opthalmic
Ascheberg-Trentrade, Use (Sterile)
Germany, Federal Rep. of
Tecsana Gmbh Epi-No Delphine Trainer Plus
Planegger Str 9a 85N--TS
Muenchen 9/13/06
Germany
FEI #3005092343
Vamedis Medical Products Gmbh Synvisc Hylan Syringe Kits III
Landwehrstrasse 70a 89MOZ
Muenchen, Germany 80336
FEI# 3005707669 (Product has European label which
contains indications for use not yet
approved in the United States)
6/20/06
GREECE
(manufacturer) PAP-IMI Ion Magnetic
BioElectroDynamics Conductor Device
(aka Z Electrodynamics; Unclassified --
Dr. Panagiotis (Panos) T. Pappas, owner) industry code 84
(no known street address) 1/13/03
Athens, Greece
FEI #3003891272
(importer of record)
Bio-Energy Services, Inc.
18727 Ventura Blvd.
Tarzana, CA 91356
FEI #3003668912
HONG KONG
Asia Unlimited The Shealy RelaxMate (aka RelaxEase)
Hong Kong 86H0Y
FEI #3002165857 8/27/98
Automatic Manufacturing Ltd. (Mfr) Shealy Relaxmate
Kiwuntong, Hong Kong Glasses
MID# HKAUTMANKIW 5/6/94
Azad International (HK) Limited WhisperXL mini sound II
33 Canton Road amplifier (behind the ear
TRW 1, Room 2103 hearing aid)
Kowloon, Hong Kong 12/21/94
Century International Hothouse FIR Health Lacks 510(k)
Development Ltd. Builder
Flat Rm 701 89IOB
Sino Center 582-592 11/26/01
5825 Nathan Road
Mongkok, Hong Kong
FEI# 3003381112
and
Hsin Ten Health and Wealth
International Inc.
669 Changjiang West Road
Heifei, China
FEI# 3002989940
Doo Jung H.K. Limited Pap Smear Brushes (may be II
21-D Broadway shipped as cosmetic brushes
12/F Mei Foo Sun Chuen or may be brush head only.
Laichikok, Kowloon 6/8/93
Hong Kong
ID#: HKDOOJUN21LAI
E-Y Laboratories (H.K.) Ltd HIVSCAN 1 + 2 Kit III
1/F, 23 Mei Wan Street (Human Immunodeficiency
Tsuen Wan, N.T. Virus HIV-1 & HIV-2 Test Kit)
Hong Kong 82[][][], 57YY-99
FEI# 3002806955 10/28/05
Soft Lines Limited Emjoi Body Fat Monitor AP-30 Lack of 510(k)
512 North Tower (Body Composition Analyzer) Approval
Concordia Plaza-1 74MNW
1 Science Museum Road 8/26/03
Tsimshatsui East
Kowloon, Hong Kong
FEI #1000383100
Sundries Network OC's HIV-1/2 Antibody III
International Limited HIV-1/2 Whole Blood
Flat B, 4/F, One Step Test
Kiu Fu Commercial Building 82[]--[][], 57YY[]99
300 306 Lockhart Road 9/19/01
Chai Wan, Hong Kong
FEI# 3003433783
Note: HIV diagnostic test kits are Class III device within the meaning of section 513(f)(1) of the Act and ar
e
regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and
provide results in the home in 15 minutes or less.
The test kits are imported into the U.S. through the mail and may be entered
as "samples" or for "personal use." The contents may be labeled "for
investigational use," for "research use," or "for export only." The test kits
could present a serious hazard to the public health, including possible HIV
transmission to partners and delayed access to medical care due to
misdiagnosed false negative tests. If entries are encountered, contact CBER
Import/Export Team at (301) 827-6201.
Yi Shing Co., Ltd Cool Ring Teether (Ring, Teething,
Flat 102-3, 1/f., Tung Chai Building Fluid-Filled)
86-90 Wellington Street 76K[][]KO
Hong Kong 2/9/06
FEI# 3003399181
Hungary
Ecolosion KFT. Electro Physiological Feedback Xrroid
aka QX Ltd. (EPFX);*
aka Quantum Xrroid, Ltd. Quantum Xrroid(QXCI); QXCI Accessories
aka Maitreya KFT. Scientific Consciousness Interface
Kalvaria Ter. 2 Operations System (SCIO);
H-1089 Budapest Virtual Reality Imagery (VRI);
Hungary Ascultacardiogram;
FEI# 3004444071 CLASP 32 Master Program 1 CD;
3004216495 CLASP 32 Master Program 2 CD;
Living Information Forms
Energy (L.I.F.E) System
84HCC
1/4/08
* The EPFX has a premarket notification for therapeutic biofeedback to control stress and to teach a patient t
o relax.
The EPFX was not given marketing clearance for evoked potential biofeedback technology, to read the client's
subtle energy fields, for electro-dermal screening, or for measuring the physical, mental, and emotional level
s.
NOTE: CDRH has indicated this firm/product combination meets the criteria for DWPE as per information found in
Import Alert #80-06.
INDIA
Appasamy Associates Intraocular Lens III
20, Sbi Officers' Colony 86HQL
First Street, Arumbakkam 5/16/06
Chennai 600 106, India
FEI# 3000200843
Appasamy Ocular Devices Pvt. Ltd Appavisc PFS, Hydroxypropyl Methyl III
Nh 45-A, Vadamangalam Village, Cellulose Opthalmic Solution USP 2%
Vizhuppuram Main Road Labeled for intraocular use
Pondichery, India 86LZP
FEI # 3003591781 6/19/06
Health Care Latex Ltd. Latex Condoms
A-33/A Sector 8 85HIS, 85LTZ, 85MOL
Noida (U.P.), India 5/16/05
FEI# 3004976007
International Medical Devices Freeman Universal III
17 Industrial Estate, Palam Rd. Intraocular Lenses
Bombay, India (IOL) Anterior Chamber
(Optional posterior
chamber
Style Code: IMD-AC-FA
7/6/92
M/S Suruchi International Condoms
207 Sector 7A, Faridabad 121001 85HIS, 85LTZ, 85MOL II
Haryana, India 3/15/05
FEI# 3004643702
Sandhu Exports Condoms II
3, Sant Nager 85HIS
East of Kailash 85LTZ
New Delhi 110 065 85MOL
India 3/10/05
FEI# 3003752139
Shah & Shah Intraocular Intraocular Lenses III
Lens (Pvt) Ltd 86HQL
2 Russell Street 4/10/95
H.D. Road, Joka 743512
Calcutta 700 071, India
MID: INSHASHA743CAL
FEI: 1000327725
ISRAEL
Zer Science Ltd. HIV I+II Class III
aka Zer Ltd. One-Step Test
aka Zer Hitech 7/9/98
Shatner Center 3 82[][][], 57YY-99
Jerusalem, Israel *alias 8/23/01
FEI #3000168281
NOTE:
Several FDA districts have encountered shipments of unapproved HIV diagnostic
test kits invoiced and labeled for "research use only" or "investigational use
only", and some of the kits were unlabeled.
HIV diagnostic test kits are Class III devices within the meaning of Sec.
513(f)(1) of the Act and are regulated by CBER under the current Intercenter
Agreement between CDRH and CBER.
Investigations by FDA revealed that the unapproved HIV diagnostic test kits
were intended for commercial distribution, not for "research" or \
"investigational" uses as invoiced. The unapproved diagnostic test kits claim
to detect HIV antibodies in blood or saliva and provide results in the home in
15 minutes or less. The test kits could present a serious hazard to the
public health, including possible HIV transmission to partners and delayed
access to medical care due to misdiagnosed false negative tests.
Districts encountering shipments of the unapproved HIV diagnostic test kits
should contact the CBER Import/Export Team at (301) 827-6201.
ITALY
Biorem s.r.l. SkinMaster Micro- Lacks 510(k)
Via Angrisani 18/A dermabrasion products
84043 Agropoli (SA) 79--GFD/79--GEX
Italy 1/2/02
FEI# 3003494110
M.E.D.I.Co Italia Pacemaker (Phymos ADV/VDD-M) III
Medical Electronic Devices (12/08/92)
International Co.
Via Pitagora, 15-35030 Rubano (PD)
Italy
MID# ITMEDELEISRUB
Rhein'83 S.r.l. Endosseous Implants & Abutments
Via Emilio Zago, 8 76NHA II
Bologna 76DZE II
Italy 76NRQ III
FEI# 3002807996 12/11/06
RI MOS S.R.L. Mesotherapy Needles, Hypodermic Needles II
Viale Gramsci N. 29 80F[][]MI
Mirandola, Italy 80K[][]ZH
FEI #3002926090 80K[][]ZE
10/19/05
Sa Mas S.r.l. Attila Evoluzione Electrical II
Via Tarlazzi 5 Stimulation device
31014 Colle Umberto 84GZJ
Umberto, Italy 4/12/01
FEI# 3003238077
S.M.E.I.srl Sculpture Ultrasonic Aspiration Device
(Surgical Medical Aesthetic (Sculpture Ultrasound Wave Liposculpture)
Supplies)
Via F. Negri 15 Product Code: 85MGI
15033 Cassale Monferrato 1/22/99
Alessandria, Italy
FEI #3001811866
JAPAN
Daito Electric Machine Massagers, Muscle Stimulators III
Industry Co., Ltd. 84GZJ, 89ISA, 89IPF, 89MPH
9-11, Showa-Cho 89NGX
Higashi, Osaka, Japan 04/29/03
FEI # 6878
Fuji Latex Co., Ltd. Wrinkle Chapeau Condoms II
19-1, 3-Chome (7/20/93)
Kanda Nishiki-Cho, Chiyoda-Ku
Tokyo, Japan
ID# JPFULAT191CHI
Fuji Medical Instruments "New Health Club" III
Mfg. Co., Ltd. Low Frequency
5-521 Nipponbashi Therapeutic Apparatus
Naniwa-Ku, Osaka, Japan Type C, Model HC-32
MID# JPFUJMED5521OSA (8/13/93)
Hirayama Manufacturing Corp. Sterilizer, autoclave
2-16-16 Yushima, Bunkyo-Ku 75LXG
Tokyo 113 9/17/98
Japan
FEI# 1000197696
Kyocera Corporation Ceramic Aluminum and
10-1, Kawai, Gamo-cho Zirconium Balls for Hip
Gamo-gun, Shiga, 529-1595 Implants
Japan 87LZO
FEI# 3004491367 1/13/05
Kyoto Daiichi Ammonia Checker II III
Kagaku Co., Ltd Blood Ammonia Checker System
57 Nishi Aketa-cho Model AA-4120 (9/9/92)
Higashi Kujo
Minami Ku
Kyoto 601, Japan
Maramunji Sangyo Co., LTD Infant Heel Warmers
17-11-3 Ishimaru Infant Crib Warmers
Mino-Shi 12/27/94
Osaka 562, Japan
Nippon Germanium Laboratory Co., Ltd. Germanium Pellets
2-11-9 Kasuga, Shizuoka City Bandages III
Shizuoka, Japan 5/20/96
MID# JPNIPGER2119SHT
FEI# 1000548833
Sanwa Health Co. Ltd Germa Knee Sports Wrap III
39 Kamisekerya-sho Germa Adhesive Bandages III
Murasakamo, Kita-Ka
Kyoto, Japan
KOREA
Choyang Medical Co., Ltd. Choyang Dana CY5000 Physical Therapy Table III
45-1 Woebu-Ri Choyang Dana CY2000 Muscle Stimulator III
Kunbuk-Meon Choyang Dana CY1000 Muscle Stimulator III
Kumsan-Kun, Chungnam Choyang Dana JO EUN A CIM(Deluxe Heating Pad) III
Republic of Korea Choyang Dana JO EUN A CIM(Regular Heating Pad) III
FEI #3003788127 89JFB, 89MPH, 89IRT
4/23/03
Choyang Medical Co., Ltd.
398 Chujung-Ri Chubu-Myun
Gumsan-Goon Choong-Nam
Republic of Korea
FEI: 3003244884
Hesung Medical Supply Scalp Vein Sets II
517-4 Sangdaewon-Dong Infusion Sets II
Seongnam City, Seoul, Korea
Nuga Medical Co., Ltd. Nuga Best NM5000
73-1, Daessangryeong-Ri 84G[][]ZJ
Chowol-Myon, Gyeonggi-Do 89I[][]SA
Gwangju City, Republic of Korea 89I[][]PF
FEI #3004006265 89M[][]PH
89N[][]GX
4/19/05
Unis Medical Electronics Heparin Lock (PRN) II
Co., Ltd. Protected Needle II
Rm. 508, Dae Kwang Bldg 7-15 Adapter (PNA)
Nonhyun-Dong, Xangnam-Ku IV In-Line Connector II
Seoul, Korea Multiple Sample Luer II
Adapter
ID# KRUNIMED715SEO (3/5/93)
Seju Engineering Co. Ltd. Digital Alcohol I
611-1 Guam-Dong, Detector
Yusung-Ku 91DJZ
Daejeon, Korea 8/28/07
FEI #3002715876
LUXEMBOURG
Biotech Industry S.A. New Fill, Poly Lactic Implant
212 Bernard Haal (Dermal Implant for Aesthetic
L1711, Luxembourg Use)/79LMH
FEI #3003165206 4/9/01
MALAYSIA
Alang Bidara Industries Latex Patient I
Sdn Bhd, Lot 2574, Examination Gloves
Kampong Olak Lempit 80LYY, 80FMC
Kuala Langat 9/4/96
42700 Banting, Selangor
Darul Ehsan, West Malaysia
FEI# 1000565458
MID# MYALABID2574KUA
Richter Rubber Technology Sdn Bdh Condoms II
Plot 33, Kuala Ketil Industrial Estate 85HIS, 85LTZ, 85MOL
Kuala Ketil, Kedah 3/28/07
Malaysia
FEI #3004063764
MEXICO (MX)
DRA. Olga Z. de Kleiman Little Sentry Junior
175-101 Cuernavaca Infant Breathing Monitor
Col. Condesa, Mexico City, 73FLS
Mexico 6/29/00
FEI #3002589842
MONACO (MC)
1-Minute-Test Ltd HIV 1/2 Whole Blood Test Kit
13 Bd Princess Charlotte 82[][][], 57Y[][]99
Monte Carlo, Monaco 98000 11/9/99
FEI #3002848460
PAKISTAN (PK)
Gogi Enterprises Circumcision Clamps
P.O. Box 1367 85H- - FX
Sialkot, Pakistan 5/17/00
FEI #1000627636
Dar Expo
P.O. Box 356
Fatima Jinnah Rd.
Small Industries Estate
Sialkot, Pakistan
FEI #3001348390
SINGAPORE (SG)
Genelabs Diagnostics PTE LTD Helico Blot 2.0; 83LYR
85 Science Park Drive, #04-01, HEV IgM ELISA; 83--- &
The Cavendish, OraScreen HIV Rapid
Singapore Science Park Test Kits; 57YY99
Singapore 8/13/97
FEI #1000436598
OSIM International PTE, Ltd. Blood Pressure Monitors, III
240 MacPherson Road Massagers, Muscle Stimulators
#07-01 Pines Industrial Bldg. 74DXN, 74DXQ, 84GZISA
Singapore 89IPE, 89MPH, 89NGX
FEI #3000992569 04/29/03
SOUTH AFRICA (ZA)
Anytestkits HIV 2 blood test kit
Sunnyside 82- - - , 57YY99
Republic of South Africa 5/25/00
FEI # 3003016880
Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and ar
e
regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic
test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or l
ess.
The test kits are imported into the U.S. through the mail and may be entered as Asamples@ or for Apersonal use
@.
The contents may be labeled Afor investigational use@, for Aresearch use@, or Afor export only.@ The test kit
s
could present a serious hazard to the public health, including possible HIV transmission to partners and delay
ed
access to medical care due to mis-diagnosed false negative tests. If entries are encountered, contact CBER
Import/Export Team at 301-827-6201.
Ageless HIV 1/2, HIV 2 subtype O,
Box 29054 serum, plasma or whole blood
Sunnyside test kit
0132 Republic of South Africa (aka HIV/AIDS home test kit)
FEI# 3003010115 82[][][], 57Y[][]99
1/29/01
M A Meyer HIV 1/2, HIV 2 subtype O,
Box 29054 serum, plasma or whole blood
Sunnyside test kit
0132 Republic of South Africa (aka HIV/AIDS home test kit)
FEI# 3003010115 82[][][], 57Y[][]99
«9/01
Sallamander Concepts HIV 1/2, HIV 2 subtype O,
Box 29054 serum, plasma or whole blood
Sunnyside test kit
0132 Republic of South Africa (aka HIV/AIDS home test kit)
FEI# 3003134155 82[][][], 57Y[][]99
1/29/01
Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and a
re
regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and
provide results in the home in 15 minutes or less.
The test kits are imported into the U.S. through the mail and may be entered as "test kit," "samples" or for "
personal
use." The contents may be labeled "for investigational use," for "research use," or "for export only." The t
est kits
could present a serious hazard to the public health, including possible HIV transmission to partners and delay
ed
access to medical care due to misdiagnosed false negative tests. If entries are encountered, contact CBER
Import/Export Team at (301) 827-6201.
SWEDEN (SE)
Lic Care, AB BD5000 Optima Birthing Bed (10/27/92) II
Svetsarvagen 20 BD6000 Optima Birthing Bed (10/27/92) II
Solna, Sweden
Postal Address:
LIC Care, AB
5-17183 Solna, Sweden
or
LIC Rehab Care AB
Box 8164
S-163 08 SPANGA, Sweden
Q-Med AB Perlane Sodium Hyaluronic Acid &
Seminariegatan 21 75LZX, 89LZX, 89MOZ, 80LDQ
SE-752 28 Uppsala, Sweden 6/3/02
FEI #3003591725
Scandicare Products AB All devices
Depagaten 2, Box 34 Product codes: 85HFW, 79HXD
S-33400 Anderstorp, Sweden 11/21/95
FEI# 6891
MID# SESCAPRO24AND
SWITZERLAND
Bilimed AG Belimed Washing Machine Model SM 700
Ch-5608 (3/5/92) III
Stetton Belimed Scope Washing Machine Model
Switzerland SME 2000 (3/5/92) III
Belimed Washington Machine Model
SM 1000 (3/5/92) III
Compex, S.A. Compex 2 Iontophoresis (Product Code=89EGJ)
Chemin Du Devent 3/1/99
CH-1024 Ecublens
Switzerland
FEI# 3002601983
Corange International Ltd. Elecsys HBsAg
Hamilton Cham Branch Immunoassay Kits
Hinterbergstrasse 9, 11/26/97
Postbach 5146 PRODUCT CODE
Cham, Switzerland 6330 83L[][]OM
FEI#1000326892
HAMO AG Endoclean 2000, and Decontaminating II
Reinigungs-Hyglenetechnik Machines Models LS-850, LS-76, DW/T-216
Bielstrasse 76 (1/30/92)
2542 Pieterlen/Biel
Switzerland
Health Angel, Gmbh Evoked Response Electrical
Obergass 3, CH-8193 Stimulator
Eglisan/Zurich, Switzerland 84G[][]WF
FEI #3002821759 5/25/01
Home Art and Sales Zepter Cosmetics Electro-
Services AG Acupuncture Device/73BWK
Sihleggstrasse 23 12/3/03
CH 8832 Wollerau
Switzerland
FEI #3003348812
Minimally Invasive Products, GmbH Orbasone TM, aka
Kreuzlingen, Switzerland Orbasone Therapeutic Vibrator)
FEI # 3003046204 and Ossanol TM, aka
(Ossanol Therapeutic Vibrator)
89IRO - 6/29/00
TAIWAN, ROC
ACUTE IDEA CO., LTD. Pacifier Thermometer
TAIWAN, R.O.C. 3/9/94
BeautiStyle Int'l Corp. Ozone Clean & Beauty Massager
17 Hu Ja Rd., 1f, Lane 149 89I[][]RO
Taipei, Taiwan 4/29/02
FEI# 3003362156
Distributed by:
^
^
Trade Name: Paci-Temp
^
^
Trade Name: Lumiscope Baby Therm
WINTEK MICROCIRCUIT CORP. Pacifier Thermometer
Taipei, Taiwan, R.O.C. 3/9/94
Distributed by:
^
^
Trade Name: Dubby
^
^
Trade Name: Lumiscope Baby Therm
TAIWAN SHINING YOUNG TRADING Pacifier Thermometer
Co., Ltd.
Taipei, Taiwan R.O.C. 3/9/94
Trade Name: Knoble
Distributed by:
^
^
Trade Name: Lumiscope Baby Therm
Chipper-Tech Co. Brainwave Synchronizer
No. 19 Lane 53 Shwanglien St. 9/9/94
Taipei, Taiwan
Importer/Consignee:
^
^
or
^
^
Kung's Medical Instruments LYM -03-Terminator Mini Electrical III
Company, Ltd. Syringe Needle Destroyer (2/1/93)
P.O. Box 55-1620
Taipei, Taiwan, ROC
T.A. Yu Chanc Industrial Co., Ltd. Sun Eeze (fitsrite)
299 Nan Yang Road protective eye wear
Seng Yaun, Taiwan ROC (10/14/94)
UNITED KINGDOM
Abby TENS TENS Elite, Profile TENS, III
46 Cambridge Street TENS N Tone, TENS Elite Dual
Wolverton Lead, Lady TENS, 804-OB
Milton Keynes, England Obstetric TENS Unit (Abby TENS)
MK12 5AH 84G[][]ZJ
FEI# 3004022293 5/15/03
Body Clock Health Stimplus electronic acupuncture II
Care Ltd. device/73BWK
108 George Lane 5/31/01
South Woodford
London, England
FEI# 3003267895 TENS Elite, Profile TENS, III
TENS N Tone, TENS Elite Dual
Lead, Lady TENS, 804-OB
Obstetric TENS Unit (Abby TENS)
84G[][]ZJ
5/19/03
Bretherton Therapy Products Lipodren
29 Orchard Road Muscle Stimulator
Beeston, Sandy, 84NFO, 89IPF
Bedfordshire SG19 1PJ 89NGX, 89LPQ
United Kingdom 7/20/05
FEI# 3003057408
Life-Energies Ltd. Training Materials 3/13/01
The Coach House, The Avenue Introductory Training
Odstock, nr. Salisbury Level 1 Training
United Kingdom SP5 4JA Level 2 Training
FEI# 3003080568 Eliminating Electromagnetic Stress
From Your Life
Skenar (Self-Controlled
Energo-Neuro-Adaptive Regulator)
The NEW Life-Energies' Skenar 97.4
The (fully automatic) Pocket Skenar
Large Energiser Healing Blanket
Medium Energiser Healing Blanket
Small Energiser Healing Blanket
Cell-O-Matt Kit
` Computer Clear
PRODUCT CODES
84JXK (Skenar and Training
Materials)
84[][][] (Healing Blanket and Cell-
O-Matt)
The articles are considered adulterated in that they appear to be class 3
devices and do not have an approved application for premarket approval. The
articles are also considered misbranded in that it appears a notice or other
information respecting the device was not provided to the FDA as required by
Section 510(k).
Medical Wire & Equipment Co. Transwabs (MW169C,
(Bath) Ltd. MW172PT, MW172CT,
Corsham, Wiltshire, England MW174P, MW175C)
UK SN13 9RT Theater Pack, Virocult,
MID# UKMEDWIRCOR Chlamydia Transwab, Strip
tests (Beta, Pro-, Pyo,
Gram, and Indo-Test),
Micro Ring (XV, AC, AN,
and Yeast ID)
1/13/95
Sauflon Pharmaceuticals, Ltd. "i-clean" antibacterial contact
49-53 York Street lens soaking case
Twickenham, Middlesex TW1 3LP 86LRX
United Kingdom 9/3/08
FEI# 3002982796
And
Optipak, Ltd. "i-clean" antibacterial contact
(subsidiary of Sauflon Pharma) lens soaking case
49-53 York Street 86LRX
Twickenham, Middlesex TW1 3LP 9/3/08
United Kingdom
FEI# 3007096048
Savec Health Systems Omnivir Device
120 Deramore Avenue Possibly listed as:
Belfast oxygen generator
Northern Ireland 73CAW
United Kingdom 12/17/08
FEI # 3007126468
NOTE: CDRH has indicated this firm/product combination also meets the criteria for DWPE as per information
found in Import Alert #80-06.
Unipath Ltd. Personal Contraceptive Monitor
Norse Road 85MEE
Bedford, United Kingdom Class III device
FEI# 3002808416 2/5/02
Shipped by: The Garden Pharmacy
119 Long Acre
London, United Kingdom
FEI #3003110891
UKRAINE (UA)
Consultative & ENART a Tens device Claims related to
Commercial Centre 89IPF disorders of the
"INVET" 2/6/08 Central Nervous
Ac. Zabolotny St. 35/37 System, the
Odessa, Ukraine 65069 Peripheral
FEI # 3006362803 Nervous System,
the Respiratory
system, etc., as
well as dental
diseases.
Science Production Centre Viatec Arbor Test-Microscope for
Erevanska Street 31/1 Regulation of Pregnancy
Kiev, Ukraine 03087 75LCX and 88GJY
FEI# 3003018884 3/16/01
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