FDA import alert
Import Alert 89-01
Detention Without Physical Examination of Misbranded and/or Adulterated Powered Muscle Stimulators and Iontophoresis Devices
31
Red-list entries
0
Green-list entries
14
Countries
2013-12-30
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
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Red-list entries by country
Firms on this red list
Showing 31 of 31 entries — search a specific firm on the free checker.
- DR HO'S INC.
09/16/2009
Canada · Stimulator, Muscle, Powered
- DR. HO'S MUSCLE THERAPY
09/16/2009
Canada · Stimulator, Muscle, Powered
- Dr-ho's Inc
09/16/2009
Canada · Stimulator, Muscle, Powered
- Silhouet-Tone Corporation
12/30/2013
Canada · Device, Electrosurgical, Cutting & Coagulation & Accessories; Device, Iontophoresis, Other Uses; Lamp, infrared, therapeutic heating
- Hongrun Electronics
11/08/2013
China · Stimulator, Muscle, Powered; Massager, Therapeutic, Electric; Stimulator, Muscle, Powered, for Muscle Conditioning
China · Stimulator, Transcutaneous Electrical, for Cosmetic Use; Stimulator, Muscle, Powered; Stimulator, Muscle, Powered, for Muscle Conditioning
China · Stimulator, Nerve, Ac-Powered; Stimulator, Nerve; Stimulator, Transcutaneous Electrical, for Cosmetic Use
- 12m 16 Bis
09/16/2009
France · Device, Iontophoresis, Other Uses; Device, Iontophoresis, Specific Uses
- Chau Sport
09/16/2009
France · Stimulator, Muscle, Powered
- A.L.T. Lichttherapietechnik Gmbh
11/09/2010
Germany · Device, Iontophoresis, Other Uses; Device, Iontophoresis, Specific Uses
- Dr K Honle Medizintechnik Gmbh
11/09/2010
Germany · Device, Iontophoresis, Other Uses; Device, Iontophoresis, Specific Uses
- Comet Ltd
09/16/2009
Hong Kong SAR · Stimulator, Nerve, Ac-Powered; Stimulator, Nerve; Stimulator, Transcutaneous Electrical, for Cosmetic Use
- Homesquare International Ltd
09/16/2009
Hong Kong SAR · Stimulator, Muscle, Powered; Massager, Therapeutic, Electric; Massager, Therapeutic, Manual
- Formaggia S.R.L.
09/16/2009
Italy · Electrode, Cutaneous; Device, Iontophoresis, Specific Uses
- Formaggia Srl
09/16/2009
Italy · Electrode, Cutaneous; Stimulator, Muscle, Powered; Device, Iontophoresis, Specific Uses
- Sa Mas. S.r.l.
09/16/2009
Italy · Stimulator, Nerve, Transcutaneous, For Pain Relief
Japan · Stimulator, Nerve, Ac-Powered; Stimulator, Nerve; Stimulator, Transcutaneous Electrical, for Cosmetic Use
- JMEC Co., Ltd.
09/16/2009
Japan · Device, Iontophoresis, Specific Uses
- Doctors Technology Co., Ltd.
09/16/2009
Korea (The Republic Of) · Device, Iontophoresis, Specific Uses
- Esparron Limited
09/18/2012
Mauritius · Wound Cleaner, Ultrasound; Ultrasound, Skin Permeation; System ablations, low energy direct current and accessories
- Health Technology (Pty) Ltd
09/18/2012
South Africa · Wound Cleaner, Ultrasound; Ultrasound, Skin Permeation; System ablations, low energy direct current and accessories
- Compex Sa
09/16/2009
Switzerland · Stimulator, Muscle, Powered
Switzerland · Stimulator, Nerve, Ac-Powered; Stimulator, Nerve; Stimulator, Transcutaneous Electrical, for Cosmetic Use
- Home Care Technology Co., Ltd.
11/28/2011
Taiwan · Stimulator, Muscle, Powered
- Taiwan Creations Joe L. Co., Ltd.
09/16/2009
Taiwan · Physical Medicine
- Body Clock Health Care Ltd
09/16/2009
United Kingdom · Stimulator, Muscle, Powered
- Bretherton Therapy Products
09/16/2009
United Kingdom · Stimulator, Transcutaneous Electrical, for Cosmetic Use; Stimulator, Muscle, Powered; Portion of device code
- The Dezac Group
09/16/2009
United Kingdom · Physical Medicine
- Ultratone Scientific Instruments Ltd
09/16/2009
United Kingdom · Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Chan, Fong Dba
09/16/2009
United States · Stimulator, Nerve, Ac-Powered; Stimulator, Nerve; Stimulator, Transcutaneous Electrical, for Cosmetic Use
- Gloria Moore Inc
09/16/2009
United States · Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
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