Stimulator, Nerve, Transcutaneous, For Pain Relief
Neurology · 21 CFR 882.5890
Recent MDR events
500 adverse event reports on file
- NEUROMD WHOLE BODY CORRECTIVE THERAPY DEVICEJun 30, 2026InjuryNeuromd Medical TechnologiesMW5190106
- NEUROMD FOR BACK PAINJun 30, 2026InjuryNeuromd Medical TechnologiesMW5190107
- BIOWAVE CORPORATIONJun 23, 2026InjuryBiowave Corp.3004558433-2026-00002
- ROSCOEJun 22, 2026InjuryShenzhen Dongdixin Technology Co., Ltd.3005170249-2026-00003
- ROSCOEMay 28, 2026InjuryShenzhen Dongdixin Technology Co., Ltd3012316249-2026-00007
- REBUILDER NANO PRPMay 18, 2026InjuryRebuilder Medical, Inc.MW5188387
- TENS UNITMar 23, 2026InjuryUnknownMW5185638
- ROSCOEFeb 27, 2026InjuryShenzhen Dongdixin Technology Co., Ltd.3005170249-2026-00002
- TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNITFeb 10, 2026InjuryUnkMW5183655
- RELIEFBAND SPORTOct 31, 2025MalfunctionReliefband TechnologiesMW5178353
Event type breakdown
Recalls
7 recall events for this product code
- Synaptic CorpTerminatedApr 19, 2012
Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO.
Device was distributed without marketing approval.
Z-1440-2012 · View FDA record ↗ - Neuro Resource Group IncTerminatedApr 28, 2011
Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport packaged with Triad alcohol wipes. The alcohol
Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.
Z-2105-2011 · View FDA record ↗ - Avazzia, IncTerminatedSep 1, 2007
Avazzia Tennant Biomodulator; Model: BEST AV-1; P/N #TB04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
Z-1207-2007 · View FDA record ↗ - Avazzia, IncTerminatedSep 1, 2007
Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
Z-1208-2007 · View FDA record ↗ - Avazzia, IncTerminatedSep 1, 2007
Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
Z-1209-2007 · View FDA record ↗ - Avazzia, IncTerminatedSep 1, 2007
Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
Z-1210-2007 · View FDA record ↗ - RehabilicareTerminatedJun 17, 2003
Line Powered RePak, Model Number 1785S
If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.
Z-0931-03 · View FDA record ↗
Registered firms
370 firms currently registered for this product code
Truerelief
Santa Monica, CA, US
Motive Health, Inc.
Tempe, AZ, US
Body Clock Health Care Ltd
LONDON, ENGLAND London, City of, GB
Biowave Corporation
NORWALK, CT, US
Djo, Llc
Carlsbad, CA, US
Weero Co., Ltd.
Suwon-si,Gyeonggi-do, KR
Axion Usa Llc
Carteret, NJ, US
Everlife Medical Equipment Co., Ltd.
New Taipei City, TW
Vive Health Llc
Naples, FL, US
Fuji Dynamics Limited
Dongguan Guangdong, CN
C.m.p. Canadian Medical Products Inc.
Aurora Ontario, CA
Systec Engineering, Llc
Euless, TX, US
Dongguan Bohuikang Technology Co.,ltd
Dongguan Guangdong, CN
Pain Management Technologies
AKRON, OH, US
Zimmer Medizinsysteme Gmbh
NEU-ULM Bavaria, DE
Famidoc Technology Co., Ltd
Dong Guan Guangdong, CN
Shenzhen Xft Medical Limited
Shenzhen Guangdong, CN
Cardinal Health
Wabasha, MN, US
Rebuilder Medical, Inc.
Charles Town, WV, US
Novo Surgical, Inc.
Westmont, IL, US
Amrex-zetron, Inc.
Paramount, CA, US
Joicom Corporation
Eastvale, CA, US
Preferred Depot
Irvine, CA, US
510(k) clearances
606 clearances for this product code
- Algiamed Technologies USA, Inc.May 28, 2026
K252712 · STIMPOD NMS460 Nerve Stimulator
- SublimedJan 16, 2026
K252767 · actiTENS mini
- N & C Holdings, LLCAug 15, 2025
K252236 · CP Relief Wand Rx - TENS/NMES
- Tenscare, Ltd.Aug 30, 2024
K232441 · Unipro (K-UNIPRO-US)
- Zynex Medical OfficerAug 27, 2024
K241228 · TENSWave
- Oriental Inspiration LimitedApr 19, 2024
K233046 · Electrical Neuromuscular Stimulator, Cure Trio
- Wuxi Jiajian Medical Instrument Co., Ltd.Jan 24, 2023
K222879 · Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
- Fast Track Technologies, Inc.Sep 14, 2022
K212618 · iRelieve Microcurrent Pain Relief System