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IA #89-01 -
Revised 3/19/97, "Electrical Muscle Stimulators and Iontophoresis
Devices", Attachment I, 10/26/06, II, 7/18/06 *Note: This import alert
is reissued to update the format, product code, and Center contact person.
Changes and updates are identified with an asterisk (*).* TYPE OF ALERT:
Intensified Coverage *(Note: This import alert contains guidance to FDA field
personnel only. It does not establish any requirements, or create any rights
or obligations on FDA or on regulated entities.)* PRODUCT: Electrical Muscle
Stimulators and Iontophoresis Devices PRODUCT CODES: *89IPF (Muscle
Stimulators) 89KTB (Iontophoresis)* PROBLEM: Labeling - These electrical
devices are prescription devices and are misbranded when labeled for lay use.
In addition, the muscle stimulators are misbranded when inappropriate claims,
such as weight reduction, are made. PAC: 82007 COUNTRY: All MANUFACTURER/
SHIPPER: Various (see attachment) CHARGE: If appropriate, charge: Devices
lacking prescription legend or otherwise not in compliance with 21 CFR
801.109: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a prescription device labeled for
lay use, and thus lacks adequate directions for its use [Misbranded,
502(f)(1)]." Devices with inappropriate claims: "The article is
subject to refusal of admission pursuant to section 801(a)(3) in that it
appears to lack adequate directions for its intended use [Misbranded,
502(f)(1)]." Devices with labeling claims that are false and misleading:
"The article is subject to refusal of admission pursuant to section
801(a)(3) in that its labeling appears to be false or misleading [Misbranded,
502(a)]." Devices marketed without premarket notification: "The
article is subject to refusal of admission pursuant to Section 801(a)(3) in
that it appears that a premarket notification was not submitted pursuant to
section 510(k) [Misbranded, 502(o)]." Charges may be combined as
appropriate. Note: Depending on the actual electromechanical configuration of
the device it may also be misbranded within the meaning of Section 502(f)(2).
RECOMMENDING OFFICE: CDRH and SAN-DO REASON FOR ALERT: The use of these
electrical devices in health clubs, beauty salons and figure salons has been
increasing for several years. While there are legitimate uses for both muscle
stimulators and iontophoresis devices, they are prescription devices and are
misbranded when labeled for lay use. In addition, muscle stimulators are
misbranded when any of the following claims are made: girth reduction, loss
of inches, weight reduction, cellulite removal, bust development, body
shaping and contouring, and spot reducing. A large number of these products
are imported with the list increasing (see attachments I and II). The
following information is provided to aid the districts in identifying and
detaining misbranded muscle stimulators and iontophoresis devices. Muscle
Stimulators: Electrical muscle stimulators are prescription devices used to
repeatedly contract muscles by passing electrical currents through electrodes
in contact with the body. One or more pairs of electrodes, along with creams
or gels, may accompany the device, which may be powered by battery or line
voltage. There are currently no acceptable uses for these devices when
labeled for over-the-counter use. When labeled for Rx use by a licensed
practitioner, the following uses are generally recognized as acceptable: 1.
Relaxation of muscle spasm. 2. Prevention or retardation of disuse atrophy.
3. Muscle reeducation. 4. Increasing local blood circulation. 5. Immediate
postsurgical stimulation of calf muscles to prevent venous thrombosis. 6.
Maintaining or increasing range of motion. The labeling must contain the
prescription legend and comply with all the conditions of 21 CFR 801.109.
Muscle stimulators are misbranded when any of the following claims are made:
girth reduction, loss of inches, weight reduction, cellulite removal, bust
development, body shaping and contouring, and spot reducing. Iontophoresis
Devices An iontophoresis device is a prescription device used to introduce
ions of soluble salts (i.e., medications) by use of direct current into the
tissues of the body for therapeutic or diagnostic purposes. There are
currently no acceptable uses for iontophoresis devices when they are labeled
for over-the-counter use. When labeled for Rx use by a licensed practitioner,
the only approved use is the diagnosis of cystic fibrosis explained in the
final classification 21 CFR Part 890.5525, * or for use with a drug, if
labeling includes adequate directions for use of the device with that drug.*
All other uses would result in the device being considered Class III,
requiring premarket approval. The labeling for this device must contain the
prescription legend and comply with all the required information of 21 CFR
801.109. The names of these devices, the names of the companies and the
labeling claims may change in the future. Some devices are being promoted for
both muscle stimulation and iontophoresis. There is no objection to combined
labeling or use as long as the labeling requirements for both uses are met
and FDA has determined it to be substantially equivalent to preamendment
electrical muscle stimulators and iontophoresis devices. GUIDANCE: *Consult
the Center for Devices and Radiological Health (HFZ-343), Edgardo Santiago at
(301) 594-4659* about appropriate charges, adequate warnings, and whether
detention is warranted. *For questions or issues concerning science, science
policy, sample collection, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301) 443-3320 or 3007.* FOI: No
purging required. KEYWORDS: Electric Muscle Stim, Iontophoresis Device, Muscle
Stimulators, Slendertone. REVISED BY: Alwin Collins, O & P SDWG, DIOP,
(301) 443-6553. DATE LOADED INTO FIARS: MARCH 19, 1997 Import Alert #89-01
10/26/06 Attachment I KNOWN MANUFACTURERS OF ELECTRICAL MUSCLE STIMULATORS
Manufacturer Importer Name of Device Anti-Aging International Unknown
Electrical Muscle Inc. Stimulator 76 Hazelton Avenue 6/30/95 Toronto, Ontario
Canada M5R 2E2 MID #XOCANTAGI76TOR Shipper: Name Unknown 122 Davenport Road
Toronto, Ontario Canada MID# CAUNK122TOR Body Clock Health Care Ltd.
Electronic Muscle Stimulator 108 George Lane 89I--PF South Woodford 10/26/06
London, UK FEI# 3003267895 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 Compex S.A. Compex-Sport
Electrical Muscle Chemin du Devent Stimulator/89IPF CH-1024 Ecublens 5/23/01
Switzerland FEI #3002806744 SHIPPER: Chau Sport 5 Rue President Favre Annecy,
France FEI #3003232528 Daito Electric Machine Industry Co. Ltd Stimulator,
Muscle, Powered 9-11, Showa-Cho (body building belt) Higashi-Osaka, Japan
OSIM Pro-Therapist, FEI #1000254767 Model OS-205 73BXM, 77ETN, 84NFO, 89IPF,
89MPH, 89NGX 8/29/02 Deutsche Nemectron Nemectron Belmont Electrodyn CII,
Germany New York, NY Dermaphoresis Dezac, Ltd. Manufacturer Electronic Muscle
54 Bath Road Stimulator Dr-Ho's Inc. Dr-Ho's Muscle Massage P.O. Box 26543
Muscle Therapy Systems Markville R.P.O. 89IPF Markham, Ontario, Canada L3R0M4
4/17/00 FEI# 3002923277 Dr. Ho's Muscle Therapy 48 Norwich Drive Markham,
Ontario, Canada L3P 6R4 FEI# 3002267880 Dr. Ho's Inc. 176 Bullock Dr. #13
Markham, Ontario, Canada L3P 7N1 FEI# 3002923326 Cheltenham, Gloster 2/28/97
United Kingdom FEI #1000599629 MID #GBDEZLTD54CHE (Manufacturer) Stimulator,
Muscle, Powered Unknown (body building belt) Ab-Sonic brand (Shipper)
(Importer) "the smart electronic massage Comet (HK) Ltd. Fong Chan
fitness belt" Unit 1118-1119, Metro dba Tung Hing USA 73BXM, 77ETN, 84NFO,
89IPF, Centre II Industries Co. 89MPH, 89NGX 21 Lam Hing St., Bay 501C Poplar
Ave. 8/29/02 Kowloon, Hong Kong Millbrae, CA 94030 FEI #3003587846 FEI
#3003570103 Edith Serei Co., Ltd. Edith Serei Co., Ltd. Electromass Canada
New Jersey Formmagia S.R.L. AS 43 Suntronic Aesthetic 20089 Valleambrosia de
Rozzano (MI) Treatment Via Varalli 1, Capannone A/1, Italy 89IPF FEI#
3005787843 84GXY 07/18/06 Formmagia S.R.L. Via Giuseppe Frua 22 Milan, Italy
FEI# 3002928645 Generali Tecniche P-Ryton Corp. Dermaphoresis,
Elettroestetiche, Italy Long Island City, NY Vibroelectronic 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 International Esthetics Global
Esthetics Multitone Muscle- Corporation Seattle, WA toner North Vancouver,
B.C. Multitone Trans- Canada dermal Facial Unit Shipper: Global Esthetics
Vancouver, B.C., Canada Mayfair Medical Supplies The Scarf Co. Slim-up
Kowloon, Hong Kong Acupunture Equipment Beauty Pulse & Tens Tucson, AZ
85705 Sa Mas S.r.l. N/A Attila Evoluzione Via Tarlazzi 5 Electrical
Stimulation 31014 Colle Umberto device Umberto, Italy 84GZJ FEI# 3003238077
4/11/01 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 Futian Light Industrial N/A Stimulator, Muscle, Powered &
Textile Products Import & (body building belt) Export Co. 73BXM, 77ETN,
84NFO, 89IPF 6/F Futian Trade & Business Building 89MPH, 89NGX Fuhua Road
51 6/20/02 Shenzhen, China FEI #3003606121 Slendertone Ltd. Bloomex Int't.
Slendertone England New York, NY Taiwan Creations Joe L. Co., Ltd. Home Slim
Taipei, Taiwan Healthtronic, Muscle Stimulator and Slimming System 2/1/94
Alpha-wave Healthtronic, Muscle Stimulator and Slimming system 2/1/94 Ultra
Scientific Instruments `Gloria Moore Inc. Ultratone EMS devices, Ltd.(aka
Ultratone) 82 Sidney Court including - Kingnorth Technology Park San Rafael,
CA Ultratone Facial Wotton Rd., Ashford, 94903 Kent TN23 6LN FEI# 300205934
Stimulator United Kingdom Ultratone Salon 10 Plus FEI# 1000313394 Ultratone
Pro 20 Ultratone Super Pro 20 Ultratone Futura Plus 89L- - PQ 5/9/01 Zot
Nederland B.V. Amsterdam N/A Stimulator, Muscle, Powered Lugano Branch
Innuelle Brand Tex-El System Corsa Elvezia 14 73BXM, 77ETN, 84NFO, 89IPF
CH-6900, Lugano, Switzerland 89MPH, 89NGX FEI# 3003426581 6/20/02 Import
Alert #89-01 7/18/06 Attachment II KNOWN MANUFACTURERS OF IONTOPHORESIS
DEVICES Manufacturers Importer Name of Device Generali Tecniche P-Ryton Corp.
Lisa Derm, Elettroestetiche, Italy Long Island City, NY Thermoslim,
Dermophoresis Vibroelectronic Deutsche Nemectron Nemectron Belmont Electrodyn
CII, Germany CII « New York, NY Doctors Technology Co. Ltd. Up5 Skin care
system- iontophoresis 614-3 Shinsa-dong, Kangnam-ku device Seoul, Korea 89KTB
FEI# 3004429497 3/26/04 Shipper: JMEC Co. Ltd. Oshima Bldg. 3-31-3 Yushima
Bunkyo-ky, Tokyo, Japan FEI# 3004429507 Edith Serei Co., Ltd. Edith Serei
Co., Ltd. Galvanique, Canada New Jersey Cathiolyse Formmagia S.R.L. AS 43
Suntronic Aesthetic 20089 Valleambrosia de Rozzano (MI) Treatment Via Varalli
1, Capannone A/1, Italy 89KTB FEI# 3005787843 84GXY 07/18/06 Formmagia S.R.L.
Via Giuseppe Frua 22 Milan, Italy FEI# 3002928645 Ionto-Comed Ionto-Comed
U.S. Inc. Ionto-Lift No. 8223 Gmbh, West Germany St. Paul, MN i2M Sarl 16 Bis
N/A Idrostar, Fosses Saint Julien Iontophoresis BP200 14011 Device Caen
Cedax, France 89EGJ, 89KTB FEI #3003614118 |
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