Import Alert 89-01

(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).

Import Alert # 89-01
Published Date: 02/24/2022
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Misbranded and/or Adulterated Powered Muscle Stimulators and Iontophoresis Devices"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 02/23/2022 updates the name of the alert, removes "surveillance" from alert type and changes to firm alert, updates the existing reason for alert and guidance section, agency contacts, PAF and PAC codes, updates charge code language, and adds new charge. Changes to the import alert are bracketed by asterisks (***).

***The use of these electrical devices in health clubs, beauty salons and figure salons has been increasing for several years. While there are legitimate over-the-counter and prescription Indications for Use for both powered muscle stimulators (e.g., muscle reeducation, relief of muscle spasm, increasing range of motion, disuse atrophy therapy, increased local blood circulation, or immediate post-surgical stimulation of calf muscles to prevent venous thrombosis) and iontophoresis devices (e.g., inducing sweating for use in the diagnosis of cystic fibrosis) reflected in several cleared 510(k) submissions for both these device types, those products deemed prescription devices require specific labeling as detailed under 21 CFR 801.109. In these instances, such products are misbranded when labeled for lay use under Federal Food, Drug, and Cosmetic Act (FD&C Act) 502(f)(1). In addition, the Agency to date has not cleared or approved any powered muscle stimulators with any of the following Indications for Use: girth reduction, loss of inches, weight reduction, cellulite removal, bust development, body shaping and contouring, and spot reducing. A powered muscle stimulator with these Indications, absent approval or clearance, provides an appearance that the firm's products are misbranded and/or adulterated.

Many of these products are imported from manufacturers identified on the Red List. The following information is provided to aid Divisions in identifying and detaining misbranded muscle stimulators and iontophoresis devices.

Powered Muscle Stimulators:

Powered muscle stimulators are 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. These include, but are not limited to, products that may be covered by codes IPF and NGX. These products can be cleared for prescription or OTC use. If they are prescription devices, they must include a prescription legend and meet all other applicable conditions under 21 CFR 801.109.

Powered muscle stimulators may be cleared for such uses as relaxation of muscle spasms, prevention or retardation of disuse atrophy, muscle reeducation, increasing local blood circulation, immediate postsurgical stimulation of calf muscles to prevent venous thrombosis, and maintaining or increasing range of motion. FDA's 510(k) Premarket Notification database may be consulted for cleared indications for use for powered muscle stimulators under the above-referenced product codes.

There are no powered muscle stimulators that are currently cleared or approved for any of the following indications for use: girth reduction, loss of inches, weight reduction, cellulite removal, bust development, body shaping and contouring, and spot reducing. Because these Indications are outside the scope of any applicable device clearances or approvals, their use on a product label provides an appearance that a powered muscle stimulator is misbranded and/or adulterated.

Iontophoresis Devices:

An iontophoresis device is a prescription device used to introduce ions of soluble salts or drug (i.e., medications) by use of direct current into the tissues of the body for medical (i.e., diagnosis, cure, mitigation, or treatment of disease) purposes. These include, but are not limited to, products that may be covered by product codes EGJ and KTB.

Iontophoresis devices may be cleared for such uses as inducing sweating for use in the diagnosis of cystic fibrosis, and iontophoretic dermal administration of a specific drug (e.g., lidocaine hydrochloride). These uses are regulated under 21 CFR 890.5525(a) and may be cleared for either prescription use or over-the-counter use.

Iontophoresis devices may also be cleared for uses other than those identified in 21 CFR 890.5525(a), meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device. These other uses are regulated under 21 CFR 890.5525(b). Such cleared uses include but are not limited to treatment of hyperhidrosis (i.e., excessive sweating), and administration of soluble salts into the body for medical purposes. FDA's 510(k) Premarket Notification database may be consulted for cleared indications for use for iontophoresis devices under the above-referenced product codes. For those uses regulated under 21 CFR 890.5525(b), the device must conform to the special controls identified in 21 CFR 890.5525(b)(i).

If an iontophoresis device is not cleared or approved for any of the uses described in the above paragraphs, or for any other cleared use, their use on a product label provides an appearance that the product is misbranded and/or adulterated.

The labeling for prescription iontophoresis devices must also contain the prescription legend and comply with all other applicable conditions in 21 CFR 801.109.

The names of these devices, the names of the companies, and the labeling may change in the future. Some devices are being promoted for both muscle stimulation and iontophoresis. There may be no objection to combined labeling or use if the labeling requirements for both these uses are met and FDA has determined the device to have the required premarket authorization(s). ***

Guidance:

***Divisions may detain, without physical examination, shipments of the indicated devices from the firms identified on the Red List of this import alert.

Recommendations for addition to DWPE under this Import Alert should include any supporting documentation, including, but not limited to analytical worksheets (if the product was analyzed), inspection reports, labeling, package inserts, user manuals, photographic evidence, website information, entry documents, etc. DIO will coordinate a review of all recommendations with CDRH Imports and Registration & Listing Team.

Release of devices subject to detention without physical examination under this import alert:

In order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment may either (1) opt to present testimony to the FDA in the form and manner specified by the Notice of FDA Action, or (2) submit to the FDA a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning). Divisions will refer such applications related to this alert to CDRH Imports and Registration & Listing Team, for concurrence.

For more information about reconditioning, please refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9, "9-12-Reconditioning." The RPM is located at FDA's website: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/regulatory-procedures-manual

For questions regarding device classification, please refer to the "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" guidance document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic

Request for removal from Detention Without Physical Examination under this Import Alert (REMOVE FROM RED LIST):

In order to remove a firm's device from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments will be in compliance with the Federal Food, Drug, and Cosmetic Act.

For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "9-8 Detention Without Physical Examination (DWPE)".

If a firm and/or a representative of the firm would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH Imports and Registration & Listing Team.

Questions or issues involving import operations, should be addressed to the Division of Import Operations at 301-796-0356, or email fdaimportsinquiry@fda.hhs.gov

For questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: cdrhimport@fda.hhs.gov

                                                                                                                                                                        ***

Product Description:

Electrical Muscle Stimulators and Iontophoresis Devices

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 is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109." [Misbranding, Sections 502(a)&(f)(1)]

OASIS charge code - RX DEVICE

Devices with inappropriate claims:

"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use." [Misbranding, Section 502(f)(1)].

OASIS charge code - DIRECTIONS

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 it is a device whose labeling appears to be false or misleading." [Misbranding, Section 502(a)]

OASIS charge code - FALSE

Devices marketed without premarket notification:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed." [Misbranding, Section 502(o)]

OASIS charge code - NO 510(K)

Note: Depending on the actual electromechanical configuration of the device it may also be misbranded within the meaning of Section 502(f)(2).

"It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users." [Misbranding, Section 502(f)(2)]

OASIS charge code: WARNINGS

Charges listed herein may be combined as appropriate. ***

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


CANADA


DR HO'S INC.
Date Published : 09/16/2009
P.O. BOX 26543 , Markville R.P.P. , Markham, ON CANADA
89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Dr-Ho's Muscle Massage Muscle Therapy Systems

DR. HO'S MUSCLE THERAPY
Date Published : 09/16/2009
48 NORWICH DRIVE , Markham, ON CANADA
89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Dr-Ho's Muscle Massage Muscle Therapy Systems

Dr-ho's Inc
Date Published : 09/16/2009
13-176 Bullock Dr , Markham, Ontario CANADA
89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Dr-Ho's Muscle Massage Therapy Systems 4/17/2000

Silhouet-Tone Corporation
Date Published : 12/30/2013
2185 Michelin St , Laval, Quebec CANADA
79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 12/30/2013

Desc: Combo Cirrus 500 Iontophoresis device
Notes: class II

79 G - - EI Device, Electrosurgical, Cutting & Coagulation & Accessories
Date Published: 12/30/2013

Desc: Iontoderm Cirrus Iontophoresis device
Notes: class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 12/30/2013

Desc: Iontoderm Cirrus Iontophoresis device
Notes: class II

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 12/30/2013

Desc: Combo Cirrus 500 Iontophoresis device
Notes: class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 12/30/2013

Desc: Combo Cirrus 500 Iontophoresis device
Notes: class II

89 I - - LY Lamp, infrared, therapeutic heating
Date Published: 12/30/2013

Desc: Iontoderm Cirrus Iontophoresis device
Notes: class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 12/30/2013

Desc: Combo Cirrus 500 Iontophoresis device
Notes: Class II

89 I - - MI Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Date Published: 12/30/2013

Desc: Iontoderm Cirrus Iontophoresis device
Notes: class II

89 I - - RO Vibrator, Therapeutic
Date Published: 12/30/2013

Desc: Iontoderm Cirrus Iontophoresis device
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/30/2013

Desc: Iontoderm Cirrus Iontophoresis device
Notes: class II

89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/30/2013

Desc: Combo Cirrus 500 Iontophoresis device
Notes: class II


CHINA


Hongrun Electronics
Date Published : 11/08/2013
2nd Fl 20th Bld Qinghu Industria , Longhua, CHINA
89 I - - PF Stimulator, Muscle, Powered
Date Published: 11/08/2013

Desc: Abtronic X2 Dual Channel Fitness Belt

89 I - - SA Massager, Therapeutic, Electric
Date Published: 11/08/2013

Desc: Abtronic X2 Dual Channel Fitness Belt

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 11/08/2013

Desc: Abtronic X2 Dual Channel Fitness Belt

Shenyang Xinzhen Medical Electronic Instrument Company
Date Published : 09/16/2009
No. 52 , North Huanghe Street , Shenyang, CHINA
84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 09/16/2009

Notes: BFGF-8 Computer Controled Weight Reducing Machine; Muscle Stimulator 7/20/2005

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: BFGF-8 Computer Controled Weight Reducing Machine; Muscle Stimulator 7/20/2005

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 09/16/2009

Notes: BFGF-8 Computer Controled Weight Reducing Machine; Muscle Stimulator 7/20/2005

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: BFGF-8 Computer Controled Weight Reducing Machine; Muscle Stimulator 7/20/2005

Shenzhen Futian Light Industrial & Textile Prod Imp & Exp Co
Date Published : 09/16/2009
51 Fuhua Road , 6/F, Futian Trade & Business Bldg , Shenzhen, Guangdong CHINA
73 B - - XM Stimulator, Nerve, Ac-Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) 6/20/2002

77 E - - TN Stimulator, Nerve
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) 6/20/2002

84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) 6/20/2002

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) 6/20/2002

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) 6/20/2002

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) 6/20/2002


FRANCE


12m 16 Bis
Date Published : 09/16/2009
Bp 200 14011 Caen Cedex , Fosses Saint Julien, FRANCE
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 09/16/2009

Notes: Idrostar; Iontophoresis Device

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 09/16/2009

Notes: Idrostar; Iontophoresis Device

Chau Sport
Date Published : 09/16/2009
5 Rue President Favre , Annecy, FRANCE
89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Compex-Sport Electrical Muscle Stimulator 5/23/2001


GERMANY


A.L.T. Lichttherapietechnik Gmbh
Date Published : 11/09/2010
Thura Mark 10 , Zorbig, GERMANY
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 11/09/2010

Desc: Idromed 5 PS Iontophoresis Device

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 11/09/2010

Desc: Idromed 5 PS Iontophoresis Device

Dr K Honle Medizintechnik Gmbh
Date Published : 11/09/2010
Viktor-Frankl-Str. 20 , Kaufering, Bavaria GERMANY
89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 11/09/2010

Desc: Idromed 5 PS Iontophoresis Device

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 11/09/2010

Desc: Idromed 5 PS Iontophoresis Device


HONG KONG SAR


Comet Ltd
Date Published : 09/16/2009
Metro Centre , 21 Lam Hing Street , Kowloon Bay, Kowloon HONG KONG SAR
73 B - - XM Stimulator, Nerve, Ac-Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand 8/29/2002

77 E - - TN Stimulator, Nerve
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand 8/29/2002

84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand 8/29/2002

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand 8/29/2002

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand 8/29/2002

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand 8/29/2002

Homesquare International Ltd
Date Published : 09/16/2009
Ever Gain Plaza Tower 2 , 88 Container Port Road , Kwai Chung, New Territories HONG KONG SAR
89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: ABGYMNIC Electronic Gymnastic Device 6/27/2002

89 I - - SA Massager, Therapeutic, Electric
Date Published: 09/16/2009

Notes: ABGYMNIC Electronic Gymnastic Device 6/27/2002

89 L - - YG Massager, Therapeutic, Manual
Date Published: 09/16/2009

Notes: ABGYMNIC Electronic Gymnastic Device 6/27/2002

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: ABGYMNIC Electronic Gymnastic Device 6/27/2002


ITALY


Formaggia S.R.L.
Date Published : 09/16/2009
Via Giuseppe Frua 22 , Milan, Milan ITALY
84 G - - XY Electrode, Cutaneous
Date Published: 09/16/2009

Notes: AS 43 Suntronic Aesthetic Treatment 7/18/2006

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 06/09/2021

Desc: AS 43 Suntronic Aesthetic Treatment

Formaggia Srl
Date Published : 09/16/2009
Valleambrosia de Rozzano (MI) , Via Varalli 1 , Capannone, ITALY
84 G - - XY Electrode, Cutaneous
Date Published: 09/16/2009

Notes: AS 43 Suntronic Aesthetic Treatment 7/18/2006

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: AS 43 Suntronic Aesthetic Treatment 7/18/2006

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 09/16/2009

Notes: AS 43 Suntronic Aesthetic Treatment 7/18/2006

Sa Mas. S.r.l.
Date Published : 09/16/2009
31014 Colle Umberto (Tv) , Via Tarlazzi 5 , Umberto, Umberto ITALY
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Date Published: 09/16/2009

Notes: Attila Evoluzione Electrical Stimulation Device 4/11/2001


JAPAN


Daito Electric Machine Industries Company, Ltd.
Date Published : 09/16/2009
Higashiosaka-Osaka 9-11 , Showa-Cho , Osaka, Osaka JAPAN
73 B - - XM Stimulator, Nerve, Ac-Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) OSIM Pro-Therapist Model OS- 205 8/29/2002

77 E - - TN Stimulator, Nerve
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) OSIM Pro-Therapist Model OS- 205 8/29/2002

84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) OSIM Pro-Therapist Model OS- 205 8/29/2002

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) OSIM Pro-Therapist Model OS- 205 8/29/2002

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) OSIM Pro-Therapist Model OS- 205 8/29/2002

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt) OSIM Pro-Therapist Model OS- 205 8/29/2002

JMEC Co., Ltd.
Date Published : 09/16/2009
3 Chome 31-3 , Yushima , Bunkyo, Tokyo JAPAN
89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 09/16/2009

Notes: Up5 Skin Care System - iontophoresis device 3/26/2004


KOREA (THE REPUBLIC OF)


Doctors Technology Co., Ltd.
Date Published : 09/16/2009
614-3 Shinsa-Dong , Kangnam-Ku , Seoul, KOREA (THE REPUBLIC OF)
89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 09/16/2009

Notes: Up5 Skin Care System - iontophoresis device 3/26/2004


MAURITIUS


Esparron Limited
Date Published : 09/18/2012
2nd Floor, Pres John Kennedy St , Port Louis, MAURITIUS
79 N - - RB Wound Cleaner, Ultrasound
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

79 N - - RJ Ultrasound, Skin Permeation
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

79 O - - AB System ablations, low energy direct current and accessories
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

80 F - - LG Cleaner, Ultrasonic, Medical Instrument
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: Class III

84 G - - ZO Device, Galvanic Skin Response Measurement
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

89 I - - PF Stimulator, Muscle, Powered
Date Published: 11/26/2012

Desc: Slimming machines muscle stimulator
Notes: class II

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III


SOUTH AFRICA


Health Technology (Pty) Ltd
Date Published : 09/18/2012
Unit 3, 6 Palmfield Road , Springfield Park, SOUTH AFRICA
79 N - - RB Wound Cleaner, Ultrasound
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

79 N - - RJ Ultrasound, Skin Permeation
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

79 O - - AB System ablations, low energy direct current and accessories
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

80 F - - LG Cleaner, Ultrasonic, Medical Instrument
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: Class III

84 G - - ZO Device, Galvanic Skin Response Measurement
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

89 E - - GJ Device, Iontophoresis, Other Uses
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: Class III

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III

89 I - - PF Stimulator, Muscle, Powered
Date Published: 11/26/2012

Desc: Slimming machines muscle stimulator
Notes: class II

89 K - - TB Device, Iontophoresis, Specific Uses
Date Published: 09/18/2012

Desc: Environ Ionzyme DFII System Ionizing Machine
Notes: class III


SWITZERLAND


Compex Sa
Date Published : 09/16/2009
Chemin Du Devent , Ecublens, SWITZERLAND
89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Compex-Sport Electrical Muscle Stimulator 5/23/2001

ZOT Nederland B.V. Amsterdam, Lugano Branch
Date Published : 09/16/2009
Corso Elvezia 14 , Lugano, Ticino SWITZERLAND
73 B - - XM Stimulator, Nerve, Ac-Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered Innuelle Brand Tex-El System 6/20/2002

77 E - - TN Stimulator, Nerve
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered Innuelle Brand Tex-El System 6/20/2002

84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered Innuelle Brand Tex-El System 6/20/2002

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered Innuelle Brand Tex-El System 6/20/2002

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered Innuelle Brand Tex-El System 6/20/2002

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered Innuelle Brand Tex-El System 6/20/2002


TAIWAN


Home Care Technology Co., Ltd.
Date Published : 11/28/2011
116, Lane 523, Section 3 , Jhongjheng Rd, Rende District , Tainan City, TAIWAN
89 I - - PF Stimulator, Muscle, Powered
Date Published: 11/28/2011

Desc: Muscle Stimulator (EMS HT326L)
Notes: Class II

Taiwan Creations Joe L. Co., Ltd.
Date Published : 09/16/2009
NO. 7, 5 F , Lane 235; Pao-Chiao Road , Shin-Tien City Taipei, TAIWAN
89 - - - -- Physical Medicine
Date Published: 09/16/2009

Notes: Home Slim Healthtronic; Muscle Stimulator and Slimming System. Alpha-wave Healthtronic; Muscle Stimulator and Slimming System


UNITED KINGDOM


Body Clock Health Care Ltd
Date Published : 09/16/2009
108 George Lane , SOUTH WOODFORD , London, UNITED KINGDOM
89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Electronic Muscle Stimulator 10/26/2006

Bretherton Therapy Products
Date Published : 09/16/2009
29 Orchard Road , Sandy, Bedfordshire UNITED KINGDOM
84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 09/16/2009

Notes: Lipodren Muscle Stimulator 7/20/2005

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Lipodren Muscle Stimulator

89 L - - PQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Date Published: 09/16/2009

Notes: Lipodren Muscle Stimulator 7/20/2005

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: Lipodren Muscle Stimulator 7/20/2005

The Dezac Group
Date Published : 09/16/2009
54-56 Bath Road , Cheltenham, UNITED KINGDOM
89 - - - -- Physical Medicine
Date Published: 09/16/2009

Ultratone Scientific Instruments Ltd
Date Published : 09/16/2009
Kingsnorth Industrial Estate , Wotton Road , Ashford, Kent UNITED KINGDOM
87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 06/09/2021

Desc: Ultratone Facial Stimulator; Ultratone Salon 10 Plus; Ultratone Pro 20; Ultratone Super Pro 20;Ultratone Futura Plus
Notes: Ultratone EMS devices 5/9/2001


UNITED STATES


Chan, Fong Dba
Date Published : 09/16/2009
501 Poplar Ave Apt C , Millbrae, CA 94030-1825 UNITED STATES
73 B - - XM Stimulator, Nerve, Ac-Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand

77 E - - TN Stimulator, Nerve
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand

84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand

89 I - - PF Stimulator, Muscle, Powered
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand

89 M - - PH Stimulator, Electrical, Muscle
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand

89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning
Date Published: 09/16/2009

Notes: Stimulator; Muscle; Powered (body building belt)- Ab-Sonic brand

Gloria Moore Inc
Date Published : 09/16/2009
107 Oak Grove Dr , Novato, CA 94949-7231 UNITED STATES
87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Date Published: 06/09/2021

Desc: Ultratone Facial Stimulator; Ultratone Salon 10 Plus; Ultratone Pro 20; Ultratone Super Pro 20;Ultratone Futura Plus
Notes: Ultratone EMS devices