Stimulator, Electrical, Transcutaneous, For Arthritis
Neurology · 21 CFR 882.5890
Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
Recent MDR events
9 adverse event reports on file
- SELECT 1.5Jul 2, 2012InjuryEmpi, Inc.1721293-2012-00003
- RS-OA KNEE SYSTEMMar 4, 2011OtherRs Medical1644243-2011-00006
- BIONICARE KNEE DEVICEFeb 11, 2008InjuryBionicareMW5005423
- BIONICARE KNEE DEVICEJan 11, 2008InjuryBionicare Medical Technologies, Inc.MW5004969
- BIONICARE KNEE DEVICENov 13, 2007OtherBionicare Medical Technologies, Inc.MW5004391
- BIONICARE KNEE DEVICEOct 30, 2007InjuryBionicareMW5004222
- BIONICARE KNEE DEVICEAug 14, 2007OtherBionicare Medical Technologies, Inc.MW5003450
- BIONICARE KNEE DEVICEAug 14, 2007InjuryBionicare Medical Technologies, IncMW5003451
- BIONICARE KNEE DEVICEAug 14, 2007InjuryBionicare Medical Technologies, IncMW5003452
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
140 firms currently registered for this product code
Guangzhou Longest Medical Technology Co., Ltd.
Guangzhou Guangdong, CN
Djo, Llc
Carlsbad, CA, US
Andon Health Co., Ltd
TIANJIN, CN
Hong Kong Medsourcing Limited
KOWLOON, HK
Excelhealth Inc.
Colleyville, TX, US
P Scientific Sdn. Bhd.
Masai Johor, MY
Syrma Johari Medtech Limited
Jodhpur Rajasthan, IN
Dj Orthopedics De Mexico, S.a. De C.v.
TIJUANA Baja California, MX
Guangzhou Xinbo Electronic Co., Ltd
guangzhou Guangdong, CN
Compass Health Brands (corporate Office)
Middleburg Heights, OH, US
Amg Medical Inc.
MONTREAL Quebec, CA
Mettler Electronics Corp.
ANAHEIM, CA, US
Pdi Works, Llc
Cleveland, TN, US
Omron (dalian) Co., Ltd. (plant 1)
DALIAN Liaoning, CN
Jiangxi Royall Smart Technology Co., Ltd.
Ganzhou Jiangxi, CN
Shenzhen Hengbosi Industrial Co., Ltd.
Shenzhen Guangdong, CN
Well-life Healthcare Limited
Jhonghe Taipei, TW
Actegy Ltd.
Bracknell, GB
Gemore Technology Co., Ltd.
TAN SHUI New Taipei, TW
Beijing Choice Electronic Technololgy Co., Ltd.
BEIJING, CN
Hong Qiangxing (shen Zhen) Electronics Limited
Shenzhen Guangdong, CN
Sublimed
Moirans Auvergne-Rhone-Alpes, FR
510(k) clearances
8 clearances for this product code
- Vision Quest Industries, Inc.Mar 23, 2015
K142236 · BioniCare Hand System
- Seven Seas Distribtion and Manufacturing, LLCNov 10, 2011
K111557 · X-FORCE
- Pain Management TechnologiesJul 30, 2008
K073386 · JOINT STIM, MODEL 1000
- Rs MedicalApr 13, 2007
K062325 · RS-4I MUSCLE STIMULATOR FAMILY
- Bionicare Medical Technologies, Inc.Dec 5, 2005
K052625 · BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
- Bionicare Medical Technologies, Inc.Jun 6, 2003
K030332 · MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
- Murray ElectronicsMar 15, 1999
K983228 · BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
- Murray ElectronicsJul 22, 1997
K971437 · BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000