Stimulator, Nerve, Transcutaneous, Over-the-counter
Neurology · 21 CFR 882.5890
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
Recent MDR events
118 adverse event reports on file
- TENS UNITJun 1, 2026InjuryTenscare Ltd.MW5188696
- ENSO M3Apr 1, 2026InjuryHinge Health3012640203-2026-00001
- COMPASS HEALTH BRANDSFeb 27, 2026InjuryShenzhen Dongdixin Technology Co., Ltd.3005170249-2026-00001
- ENSOFeb 23, 2026InjuryHinge Health Inc.MW5184202
- ENSO 3Jan 7, 2026InjuryHinge Health3012640203-2025-00001
- AUVONDec 2, 2025MalfunctionShenzhen Yuwen E-commerce Co., Ltd.3013957847-2025-00001
- STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTERSep 11, 2025InjuryMolufeibeMW5175905
- TENSAug 2, 2025MalfunctionHong Qiangxing (shen Zhen) Electronics Limited3010402752-2025-00001
- MOLUFEIBE TENS ELECTRODE PADSJun 20, 2025InjuryMolufeibeMW5171644
- AUVON PT1 PRO RECHARGEABLE TENS DEVICEJun 2, 2025MalfunctionShenzhen Yuwen E-commerce Co., Ltd.MW5170962
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
456 firms currently registered for this product code
Easymed Instruments Co., Ltd.
Daliang, Shunde, Foshan Guangdong, CN
Hivox Biotek Inc.
New Taipei City, TW
Djo, Llc
Carlsbad, CA, US
Praywise Technology (dongguan) Co., Ltd
Dongguan City Guangdong, CN
Excelhealth Inc.
Colleyville, TX, US
Ansion Technology (guangdong) Co., Ltd.
Dongguan Guangdong, CN
Bozhou Rongjian Medical Appliance Co., Ltd.
Bozhou Anhui, CN
Shenzhen Sinrel Tech Ltd
Shenzhen Guangdong, CN
Uan Healthcare Limited
CENTRAL, HK
Smart Recovery Technologies Llc
Quakertown, PA, US
Etekcity Company Limited
Macau, MO
Shanghai Foreign Trade Enterprises Pudong Co., Ltd.
Shanghai, CN
Andon Health Co., Ltd
TIANJIN, CN
Chongqing Rob Linka Science And Technology Co., Ltd.
Chongqing, CN
Dongguan Quanding Medical Supplies Co., Ltd
Dongguan Guangdong, CN
Hong Kong Medsourcing Limited
KOWLOON, HK
Pain Management Technologies
AKRON, OH, US
Shenzhen Jiantuo Electronics Co., Ltd
Shenzhen Guangdong, CN
Electronic Waveform Lab, Inc.
Huntingtn Bch, CA, US
510(k) clearances
229 clearances for this product code
- Shenzhen Dongdixin Technology Co., Ltd.Jun 26, 2026
K260412 · TENS 7000 Rechargeable 4 Channel (TENS 7000H)
- Hivox Biotek, Inc.Jun 16, 2026
K260425 · TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
- Globalcare Medical Technology Co., Ltd.Mar 4, 2026
K253896 · TENS/EMS device (GUSE01)
- Shenzhen Jiantuo Electronics Co., Ltd.Dec 31, 2025
K253305 · TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
- Dynapulse MedicalDec 23, 2025
K251958 · VEINOPLUS Back
- Hong Qiangxing (Shenzhen) Electronics LimitedDec 23, 2025
K253740 · TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
- Bozhou Rongjian Medical Appliance Co., Ltd.Nov 24, 2025
K252688 · Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
- Everyway Medical Instruments Co.,LtdNov 21, 2025
K251856 · Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4