IA #80-06 - 9/28/92, "Automatic Detention of Fraudulent and Deceptive Medical
Devices", Attachment - Revised 12/17/08
TYPE OF ALERT : Automatic Detention
PRODUCT : Fraudulent and deceptive medical devices
(See Attachment)
PRODUCT CODE : 80-------
HARMONIZED
CODE : N/A
PROBLEM : Distribution of medical devices determined to be fraudulent
and deceptive due to unsubstantiated labeling claims (DVFR)
PAC FOR
COLLECTION : 82002
COUNTRY : All importing countries (multiple, 999)
MANUFACTURER/
SHIPPER : All
MANUFACTURER
SHIPPER I.D.# : N/A
IMPORTER'S
I.D.# : N/A
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a device which
is misbranded in that its labeling is false or misleading"
[Misbranding, Section 502(a)]."
RECOMMENDING
OFFICE : CDRH, Division of Compliance Operations, Regulatory
Guidance Branch, (HFZ-323)
REASON FOR
ALERT : Devices listed in the Attachment are misbranded due to
false or misleading labeling claims
INSTRUCTIONS : Automatically detain all designated devices from
importation into the United States.
FOI : No purging is required
KEYWORDS : Fraudulent, deceptive, misbranded, devices
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
Attachment to IA #80-06 Revised 12/17/08
ARTICLE CLAIMS
All Intraocular Lenses Manufactured Counterfeit PMMA intra-
in Pakistan (PK) ocular lenses. Packaging
86H[][]QL may show manufactured by
Class III Device Rayner's Ltd., U.K.
10/5/01
Amulets (ornamental articles worn Therapeutic claims of next to the body,
as on a necklace,
physiological capabilities
bracelet, or carried in pockets), i.e.,"shielding "alignment", on the body
magnets etc.
Small, polished, circular "dots" Any reference to acupressure,
to be used singly (stuck on the or meridian therapy to achieve
body), or grouped (such as on an a therapeutic effect.
insole to be worn in the shoes).
Quartz Crystals, usually worn Any therapeutic capabilities
as a necklace or body jewelry. derived from the quartz or its
emissions (energy).
Pyramid Tents (various sizes) Any therapeutic claims related
to concentrating the "power"
of the sun, when properly
aligned magnetically, to
achieve any beneficial effect.
Therapeutic Blankets or Therapeutic claims such as
mattresses usually filled with blood pressure or
lambs wool. any physiological action.
Includes claims of general
well being.
"Roller" therapy products. Any claims of therapeutic
These are banks of rollers capability including
or cones to be drawn over parts references to acupressure.
of the body, or to massage the
feet.
Ear rings and/or Ear molds Claims related to appetite
control using acupressure
points on the ear.
"Radio-active" earth filled Any therapeutic claims about
pads and pillows. the healing properties of
radio-active earth.
Miniature bar magnets to be Any therapeutic claims of
used singly or in groups, used resurgence in the body due
in mattress pads, bandages to energy induced by magnets.
to promote healing, etc.
Magnetic Band, Mens Relief of pain, stiffness and
soreness
Magnetic Band, Womens Relief of pain, stiffness and
soreness
Magnetic Knee Support Relief of pain and stiffness
Magnetic Lumbar Support Relief of Stiffness and pain in muscles
Magnetic Patch, 5/Strip Relief of pain, stiffness and
soreness
Magnetic Bead Bracelet Relief of pain, stiffness and
soreness
Magnetic Steel Necklace Relief of neck, shoulder and
back pain and stiffness;
improvement of circulation
Magnetic Men and Lady Relief of pain, stiffness and
SS Band soreness
Magnetic Twist Bead Bl. Relief of pain, stiffness and
soreness
Magnetic Twist Relief of neck, shoulder and
Bead Necklace back pain and stiffness;
improvement of circulation
Magnetic Wrist Support Relief of pain, stiffness and
soreness
Magnetic Life Field Protects biological systems Polarizerand
all forms of life from all forms of
radiation; Cancels out all x-ray effects
from such items as food and water
Magnetic Trifield Meter Current Interface with normal
transport of ions across cell
membranes
Acupuncture Magneto-Therapeutic Improved circulation,
device consisting of approximately heighten blood oxygen
10 discs used piece by piece in level, relieves pain,
affected areas etc., from the effects of
magnetic force in medical treatment
Eye massagers, (battery operated) "Massage" the eyes as
action have stimulated
the self-disciplined Known
Shipper: nerves of the eyes and
helped them to resume
Laxus Products Ltd. their normal function.
62 W 4th Ave #110 Thus the stress can be
Vancouver, B.C., Canada V5Y 1G3 released; "help promote
ID# XCLAXPRO11OVAN stronger blood circulation,
prevent near sight or short
sight; may reduce the speed of
increase of short sight;
may delay the coming of
presbyopia; may prevent
eye bags, eye-palpebral
black eyes bags or little
wrinkles around the eyes."
Magnetized drinking cup The product which include, but are not limited
to, the prevention and cure of urinary
calculus, renal calculus, thrombus,
arteriosclerosis, hypertension, oral sores and
digestive system diseases.
Ceramic Magnetic Cups The supplementary curative effect on the
calculus in the gallbladder, the bile
duct and the kidney; diabetes;
hypertension; and coronary heart disease.
Metal circular bowl entitled Any therapeutic claims the
"SUPERCONDUCTOR" including but not limited
to diabetes, leukemia,
meningitis, multiple
sclerosis, and tuberculosis.
MFR/SHIPPER:
Robert McFarland
dba Radionics Institute
411-75 Eastdale Avenue
Toronto, Ontario
Canada
Shanghai Electronics China, Peoples Ceramic Magnetic
Componen (CN, 280) Cup
816 Yan An Road 5/16/94
Shanghai, PROC
MID #CNSHAELE816SHA
Auricular Candles Effective in treatment of ear wax
with Otoska oil. build-up, hearing problems, sinus
congestion, frequent migraines
and ear aches.
4/3/96
MFR:
(Candles)
Europe Cosmetiques
3471 Bld. Thimens
St. Laurent, Quebec H4R 1 V5
Canada
MID# CAEURCOS3471SAI
MFR:
(Oil)
Nature Beaute Sante
750 Montain Sights
Montreal, Quebec
Canada
FEI# 1000481474
MID# XQNATBEA7500MON
Automatic Electronic Treats diabetes mellitus, hyperlipemia (lipid
Stimulator metabolism), atherosclerosis, relieves stress
a.k.a: Autonomous and depression, chronic constipation, sexual
Electronic Stimulator, disturbances, detoxification, ischemic heart
AES, Life Saver disease, cardiac arrhythmia, paralysis, and
(a small capsule for enhances immunity level
swallowing, inserting in
vagina, rectum, or through Product Code = DE
incision in intestine)
MFR:
Aoot, Zavod Komponent,
Factory Komponent, or
Alta Company
Ismailovskow sh71
Hotel Izmailovskow Delta
Moscow, Russia
FEI: 100058935
MID: RUFACKOM71MOS
Alta Company (same address as above)
FEI: 1000589836
MID: RUALTCOM71MOS
Kencayd Consulting Ear Candles Promotes better hear-
AKA Candela Earcandles (77[][][]) ing, better lymphatic
555 Ridley Drive 2/5/97 circulation, pressure
Victoria, B.C., Canada regulation, etc.
FEI# 3000189108
MID# XCKENCON555VIC
Q-Tech Laboratories Bio-Electric Field Relief of arthritis
Level 1\453 Ruthven St Enhancement Unit muscular aches & pains
Toowoomba QLD (EEFE)/84--- allergies, incontinence
Australia 8/30/00 Etc.
FEI #3003088672
Superior Ear Candles Ear Candles Promotes better hear-
Division of J&P Holdings (77[][][]) ing, better lymphatic
Box 137 2/5/97 circulation, pressure
Parson, B.C., Canada regulation, etc.
FEI# 3000189110
MID# XCSUPEAR137PAR
Shenzhen Supernatural Hand Supernatural Hand Super Low
Electronic Co. Ltd. Frequency Massager
903, 9/F, Bldg C. Model NM-166
Shenzhen Tainan Intlūl Bldg
Renmen S. Road Product Code = 89ISA
Shenzhen City, China 5/9/97
FEI #3000280636
Bruce Copen Enterprises Ltd. Radionic Instruments Diagnosis
Lindfield Enterprise Park (including models MK7, of internal
Lewes Road, West Sussex MK12, ASLD95, MARS III) disease
England RH16 2LX & accessories
FEI #3001746577 GPI - DE
9/3/02
AND
Sussex College of Technology
Waltham Forest Business Center
5 Blackhorse Lane
London, E17 6DS, England
FEI #3003766867
Globe Traders Inc Ethicon Prolene Mesh II Counterfeit-
15, Dr. VB Gandhi Marg 79FTL Packaging may
1st Floor, Fort 2/10/04 Show ethicon logo
Mumbai, India printed in Copper
FEI #3003249367 plate rather than
Helvetica & pouch
lacks single
piece of adhesive
backing
High Hope International Group Prolene Sutures Counterfeit-
91 Baixia Road 79GAW Package labeling
Nanjing, China 11/8/05 may indicate
FEI# 3002718323 manufactured by
Ethicon
Heze Healthicon Medical Instruments Co. Ltd.
12 Jie Fang Da Jie
Heze Shandong, China
FEI# 3004947929
S.A. Wilson Coffee Enemas Liver detoxification
2891 Regional Rd.#20 Unit #2 78F--CE Pancreatic cancer
Bowmanville, Ontario 2/23/07 detoxification
Canada L1C 3K6 Relief from migraines
FEI# 3005507009
^ ^
Ecolosion KFT. Electro Physiological "Bio-energetic
aka QX Ltd. Feedback Xrroid (EPFX);* medicine" for the
aka Quantum Xrroid, Ltd. Quantum Xrroid treatment of
aka Maitreya KFT. Consciousness Interface disease or
adverse
Kalvaria Ter. 2 (QXCI); QXCI Accessories; medical
conditions
H-1089 Budapest Scientific Consciousness
Hungary Interface Operations System (SCIO);
FEI# 3004444071 Virtual Reality Imagery (VRI);
3004216495 Ascultacardiogram;
CLASP 32 Master Program 1 CD;
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 to 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 levels.
NOTE: CDRH has indicated this firm/product combination meets the criteria for
DWPE as per information found in Import Alert #89-08.
SHIPPER PRODUCT/PRODUCT CODE PROBLEM
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.
ARTICLE CLAIMS
PAP-IMI Device Promoted for use in treating immune system
Unclassified Conditions, liver and prostate cancer, prostate
Industry Code 84 Gland disorders, bone or joint diseases,
arthritis, lupus, heart disease, high blood
pressure, and diabetes.
7/8/08
SHIPPER PRODUCT/PRODUCT CODE PROBLEM
The Quantum Alliance Electro Physiological The firm's website
Corporate Headquarters Feedback Xrroid (EPFX), contains statements
27 Cougar Ridge View SW software (CLASP32 - which represent or
Calgary, Alberta MASTER Program), and suggest that the device
Canada T3H 4X3 accessories is adequate and
FEI #3006463073 84HCC effective. The
9/24/08 representations or
suggestions are false
or misleading or other-
wise contrary to fact
because the device is
Not adequate or
effective for stated
purposes.
NOTE: CDRH has indicated this firm/product combination meets the criteria
for DWPE as per information found in Import Alert #89-08.
Manufacturer Product/Product Code
Savec Health Systems Omnivir Device
120 Deramore Avenue Possibly listed as:
Belfast oxygen generator
Northern Ireland
United Kingdom 73CAW
FEI # 3007126468 12/17/2008
PROBLEM:
Product labeling for the Omnivir device contains statements which represent or
suggest the device is adequate and effective to "Fight HIV/AIDS and related
opportunistic infections and protecting the immune system," which
representations or suggestions are false or misleading or otherwise contrary
to fact because the device is not adequate or effective for such purposes.
NOTE: CDRH has indicated this firm/product combination also meets the
criteria for DWPE as per information found in Import Alert #89-08.
Attachment Import Alert #80-06 Revised 5/16/94 Page 4
DEVICES EXCLUDED FROM THIS IMPORT ALERT
The following devices are excluded from coverage under this Import Alert and
any investigation of such devices should not be included.
a. Devices intended exclusively for use upon
animals (non-human), check with the Center for
Veterinary Medicine.
b. Prescription devices, which are being marketed as such.
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