IA#89-13, -----7/31/00
SUBJECT: IMPORT ALERT #89-13, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF ELECTRODE LEAD WIRES AND PATIENT CABLES
THAT DO NOT COMPLY WITH THE APPLICABLE PERFORMANCE
STANDARD." ATTACHMENT REVISED 6/27/02
*** This import alert is being revised to correct some of the
product codes for electrode lead wires and patient cables per the
second phase of the performance standard that became effective
May 9, 2000. These are identified with a single asterisk (*)
preceding the citation. ***
This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or product(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.
TYPE OF ALERT : Detention Without Physical Examination
PRODUCT : Patient Cables and Electrode Lead Wires
PRODUCT CODES : See Product Code Attachment
PROBLEM : Nonconformance With Performance Standard
PAF : PER
PAC : 82008
COUNTRY : See Attachment
MANUFACTURER/SHIPPER: See Attachment
CHARGE : The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that the
article appears to be a device which is subject
to a performance standard established under
Section 514 and does not appear to be in all
respects, in conformity with such standard.
[Adulteration - Section
501(e)] (OASIS CHARGE CODE = FAILS STD)
RECOMMENDING OFFICE : Center for Devices and Radiological
Health, Office of Compliance, HFZ-300.
REASON FOR ALERT : A performance standard was promulgated for
electrode lead wires and patient cables to
assure their safe use. As of May 9, 2000,
this standard applies to all electrode
wires and patient cables used with
all devices unless
there is a specific variance or exemption
issued by CDRH. Those shipments of
electrode lead wires and patient
cables, which do not conform to this
standard, should be placed under detention
without physical examination and
subsequently refused entry if not brought
into compliance. Once evidence is
provided that the electrode lead wires and
patient cables comply with this standard
(or an approved variance or exemption),
they will be removed from this alert. A
list of approved variances and exemptions
will be posted on the CDRH web site at
www.fda.gov/cdrh.
GUIDANCE : Districts may detain entries of those
shipments of patient cables and lead wires
from manufacturers listed on this alert.
These entries should be detained until
evidence is submitted which overcomes the
appearance of a violation. (Such evidence may
include conducting field exams, as well as
providing the Affirmation of Compliance
Code (A of C Code = LWC), documentation such
as photographs, certificates of compliance
from the manufacturer, etc.). If districts
have questions about the reliability of
submitted documentation the district
should contact Stewart Crumpler, (301) 594-
4659, CDRH, Office of Compliance, Division of
Enforcement III, for guidance.
Shipments of patient cables and electrode
lead wires which have been physically
examined and found to be non-
compliant with the standard should be
detained and subsequently refused entry if
not brought into compliance. A
recommendation should be submitted to
place the firm/product on detention without
physical examination under this alert.
Recommendations for detention without
physical examination should be sent to the
Division of Import Operations and Policy
(DIOP) (HFC-170), which has direct
reference authority for detention without
physical examination for these devices. A
copy of the recommendation should also be
sent to Stewart Crumpler, CDRH/Office of
Compliance, Division of Enforcement III.
Manufacturers and importers who have been
listed on this alert should be encouraged
to contact CDRH to discuss bringing future
shipments into compliance. General
questions or requests for guidance
regarding the new performance standard
should be directed to CDRH, HFZ-340,
Stewart Crumpler, (301) 594-4659.
FOI : No purging required.
KEYWORDS : International Electrotechnical Commission
(IEC),Patient Cables, Electrode Lead
Wires, Electrical, Adulteration
PREPARED BY : Stewart Crumpler, CDRH, (301) 594-4659
Fredda C. Shere-Valenti, DIOP, (301) 443-
6553
DATE LOADED INTO FIARS: JULY 31, 2000
PRODUCT CODES ATTACHMENT
All references to the Code of Federal Regulations (CFR) are in
Title 21
CFR 868.2375 73BZQ - Breathing Frequency Monitor
CFR 868.2375 73FLS - Ventilatory Effort Monitor (Apnea
Detector)
* CFR 868.2775 73KOI - Electrical Peripheral Nerve
Stimulator
CFR 870.2340 74DPS - Electrocardiograph
CFR 870.2310 74DQH - Cardiograph, Apex (Vibrocardiograph)
CFR 870.1425 74DQK - Programmable Diagnostic Computer
* CFR 870.1330 74DQX - Catheter Guide Wire
CFR 870.2910 74DRG - Radio Frequency Physiological Signal
Transmitter and Receiver
CFR 870.5300 74DRK - High Energy DC-Defibrillator
(including Paddles)
CFR 870.5550 74DRO - External Transcutaneous Cardiac
Pacemaker (Noninvasive)
CFR 870.2060 74DRQ - Transducer Signal Amplifier and
Signal Conditioner
CFR 870.2050 74DRR - Biopotential Amplifier and Signal
Conditioner
CFR 870.2300 74DRT - Cardiac Monitor (including
Cardiotachometer and Rate Alarm)
CFR 870.2350 74DRW - Electrocardiograph Lead Switching
Adapter
CFR 870.2360 74DRX - Electrocardiograph Electrode
CFR 870.2900 74DSA - Patient Transducer and Electrode
Cable (including Connector)
CFR 870.2770 74DSB - Impedance Plethysmograph
CFR 870.2800 74DSH - Medical Magnetic Tape Recorder
CFR 870.1025 74DSI - Arrhythmia Detector and Alarm
CFR 870.1100 74DSJ - Blood Pressure Alarm
CFR 870.1110 74DSK - Blood Pressure Computer
CFR 870.3850 74DSR - Carotid Sinus Nerve Stimulator
CFR 870.3720 74DTA - Pacemaker Electrode Function Tester
CFR 870.3630 74DTC - Pacemaker Electrode Function Analyzer
CFR 870.3620 74DTD - Pacemaker Lead Adapter
CFR 870.3600 74DTE - External Pacemaker Pulse Generator
CFR 870.1435 74DXG - Single Function Preprogrammed
Diagnostic Computer
CFR 870.2920 74DXH - Telephone Electrocardiograph
Transmitter and Receiver
* CFR 870.2450 74DXJ - Medical Cathode-Ray Tube Display
CFR 870.2330 74DXK - Echocardiograph
CFR 870.1130 74DXN - Non-invasive Blood Pressure
Measurement System
CFR 870.2400 74DYC - Vectorcardiograph
CFR 870.1750 74JOQ - External Programmable Pacemaker Pulse
Generator
CFR 870.2370 74KRC - Electrocardiographic Surface
Electrode Tester
CFR 870.3640 74KRE - Indirect Pacemaker Generator Function
Analyzer
CFR 870.3700 74KRG - Pacemaker Programmer
CFR 870.4200 74KRI - Cardiopulmonary Bypass Accessory
Equipment
CFR 870.5300 74LDD - Low-Energy DC-Defibrillator
(Including Paddles)
CFR 870.3680 74LDF - Temporary Pacemaker Electrode
74LIW - AC-Fibrillator
74LIX - Cardiopulmonary Resuscitation Aid
74LOR - Trans-Telephonic Resuscitator
CFR 870.2340 74LOS - ECG Analysis System
74LPA - Esophageal Pacing System
74LPD - Antitachycardia Pacing System
76LYD - Electromagnetic Bone Growth
Stimulator for Dental Use
CFR 876.1620 78EXQ - Electrical Recording Cystometer
CFR 876.1800 78EXS - Electrical Urinometer (only with
EMG electrodes)
CFR 876.1800 78EXY - Uroflowmeter (only with EMG
electrodes)
CFR 876.5130 78EZL - Balloon Retention Type Catheter
CFR 876.1620 78FAP - Cystometric (CO2) on Hydraulic
Device
CFR 876.4300 78FAR - Electrosurgical Unit
CFR 876.4300 78FAS - Urological Active Electrosurgical
Electrode
CFR 876.4300 78FBJ - Electric Cord for Transurethral
Surgical Instrument
CFR 876.4300 78FDB - Patient Plate
CFR 876.4300 78FDI - Flexible Snare
CFR 876.4300 78FDJ - Rigid Self-Opening Snare
CFR 876.4300 78FDL - Patient Return Wristlet
CFR 876.4300 78FEH - Flexible Suction Coagulator
Electrode
* CFR 876.1620 78FEN - Hydraulic Cystometric Device
CFR 876.4300 78FFI - Electrosurgical Alarm System
CFR 876.4300 78FGW - Electrical Clamp
CFR 876.4300 78FHC - Adapter to the Cord, for
Transurethral Surgical Instrument
CFR 876.4300 78FHZ - Transurethral Desiccator
CFR 876.1500 78KDO - Hot Cystoscopic Rongeur
CFR 876.4300 78KGE - Electric Biopsy Forceps
CFR 876.4300 78KNS - Electrosurgical Unit (and
Accessories)
CFR 876.5320 78KPI - Nonimplanted Electrical Stimulator
for Incontinence
CFR 876.2040 78LIL - Enuresis Alarm
78LNL - Electrical Stimulator for Sperm
Collection
78LST - Erectile Dysfunction Device (only
Cavonsometry)
78MII - Thermal Ablation Gallbladder System
CFR 878.4400 79GEI - Device, Electrosurgical, Cutting
and Coagulation and Accessories
CFR 878.4400 79JOS - Electrode, Electrosurgical
CFR 882.1870 84GWF - Evoked Response Electrical
Stimulator
CFR 882.1845 84GWK - Physiological Signal Conditioner
CFR 882.1835 84GWL - Physiological Signal Amplifier
CFR 882.1460 84GWN - Nystagmograph
CFR 882.1400 84GWQ - Electroencephalograph
CFR 882.5940 84GXC - Electroconvulsive Therapy Device
CFR 882.1610 84GXS - Alpha Monitor
CFR 882.1320 84GXY - Cutaneous Electrode
CFR 882.1350 84GXZ - Needle Electrode
CFR 882.1310 84GYC - Cortical Electrode
CFR 882.1855 84GYE - Physiological Signal Telemetry
System
CFR 882.5810 84GZI - External Functional Neuromuscular
Stimulator
CFR 882.5890 84GZJ - Transcutaneous Nerve Stimulator for
Pain Relief
CFR 882.1340 84GZK - Nasopharyngeal Electrode
CFR 882.1330 84GZL - Depth Electrode
CFR 882.1825 84GZN - Rheoencephalograph
CFR 882.1540 84GZO - Galvanic Skin Response Measurement
Device
* CFR 882.5235 84HCB - Aversive Conditioning Device
CFR 882.5050 84HCC - Biofeedback Device
CFR 882.1560 84HCJ - Skin Potential Measurement Device
CFR 882.1550 84JXE - Nerve Conduction Velocity
Measurement Device
CFR 882.5800 84JXK - Cranial Electrotherapy Stimulator
for Speech Disorder
84LIH - Interferential Current Therapy
CFR 884.5940 85HII - Powered Vaginal Muscle Stimulator
for Therapeutic Use
CFR 886.1510 86HLL - Eye Movement Monitor
CFR 886.1640 86HLT - Ophthalmic Preamplifier
CFR 886.1220 86HLZ - Corneal Electrode
* CFR 886.1510 86HMC - Diagnostic Eye Movement Monitor
CFR 886.4670 86HQC - Phacofragmentation System
CFR 886.4150 86HQE - Vitreous Aspiration and Cutting
Instrument
CFR 886.4115 86HQO - Thermal Cautery Unit
CFR 886.4100 86HQR - Radio Frequency Electrocautery
Apparatus
CFR 886.4250 86HRO - Ophthalmic Electrolysis Unit
CFR 888.1500 87KQX - AC-Powered Goniometer
CFR 888.1240 87LBB - AC-Powered Dynamometer
87LOF - Noninvasive Bone Growth Stimulator
87LWB - Scoliosis Functional Neuromuscular
Stimulator
CFR 890.5525 89EGJ - Iontophoresis Device, Other Uses
CFR 890.1175 89IKD - Electrode Cable
CFR 890.1375 89IKN - Diagnostic Electromyograph
CFR 890.1225 89IKP - Chronaximeter
CFR 890.1385 89IKT - Diagnostic Electromyograph Needle
Electrode
CFR 890.5860 89IMG - Ultrasound and Muscle Stimulator
for Use in Applying Therapeutic
Deep Heat
CFR 890.5850 89IPF - Powered Muscle Stimulator
CFR 890.1850 89ISB - Diagnostic Muscle Stimulator
CFR 890.5525 89KTB - Iontophoresis Device, Specific Uses
CFR 890.5860 89LPQ - Ultrasound and Muscle Stimulator
89MBN - Invasive Powered Muscle Stimulator
89MKD - Noninvasive Functional Walking
Neuromuscular Stimulator
CFR 892.1000 90LNH - Nuclear Magnetic Resonance Imaging
System
ATTACHMENT TO IMPORT ALERT #89-13 Revise 6/27/02
FIRM DEVICE
Homesquare Int'l, Ltd. ABGYMNIC Electronic Gymnastic Device/
Rm. 3115,31/F Hong Kong 89--GZJ
Plaza 89--NHH
188 Connaught Road West 89--IPF
Hong Kong, 89--NFO
FEI #3003538851 89--NGX
89--ISA
89--LYG
6/27/02
Ultra Scientific Instruments Ltd. Ultratone EMS devices,
(aka Ultratone) including-
Kingsnorth Technology Park Ultratone Facial Stimulator
Wotton Rd., Ashford, Kent TN23 6LN Ultratone Salon 10 Plus
United Kingdom Ultratone Pro 20
FEI # 1000313394 Ultratone Super Pro 20
Ultratone Futura Plus
89L- - PQ
5/9/01
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