Product code NUH

Current FDA Classification

Device name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Medical specialty
Neurology
Device class
2
Regulation number
882.5890
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
Definition
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Related 510(k) Records

510(k)DeviceApplicantDecision date
K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.2026-03-04
K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.2025-12-31
K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited2025-12-23
K251958VEINOPLUS BackDynapulse Medical2025-12-23
K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)Bozhou Rongjian Medical Appliance Co., Ltd.2025-11-24
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4Everyway Medical Instruments Co.,Ltd2025-11-21
K243131Triathlon ProSigma Biomedical2025-11-07
K251429OTC 4-Channel Rechargeable TENS UnitChangsha Anxiang Medical Technology Co., Ltd.2025-08-28
K250784Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)Shenzhen Yicai Health Technology Co., Ltd.2025-08-21
K2511873 in 1 TENS UNIT (TC1241, TC2241, TS1241)Changsha Anxiang Medical Technology Co., Ltd.2025-07-28
K243856TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)Shenzhen Astec Technology Co., Ltd.2025-05-29
K250360TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)Shenzhen Jiantuo Electronics Co., Ltd.2025-05-11
K250053TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)Shenzhen Jiantuo Electronics Co., Ltd.2025-05-09
K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.2025-04-09
K250033Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)Guangzhou Pinzhi Medical Technology Co., Ltd.2025-04-07
K242460Progenix Select StimProgenix, LLC2025-04-02
K242815POCKET TENS (EP-300)Hivox Biotek, Inc.2024-12-17
K243334Nooro Body & Foot Stimulator (SM9141, SM9142)Xf Agencija Limited2024-11-22
K242332Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)Shenzhen Kentro Medical Electronics Co., Ltd.2024-11-05
K242567Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)Changsha Anxiang Medical Technology Co., Ltd.2024-11-04
K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus StimulatorWell-Life Healthcare Limited2024-10-18
K241678TENS & EMS Stimulator (MHD-1083)Shenzhen Minghuangda Electronics Co., Ltd.2024-09-09
K241365Pixie Pulse (SM9068)Pixie Cup, LLC2024-08-12
K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.2024-07-22
K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116)Chongqing Rob Linka Science and Technology Co., Ltd.2024-07-19
K241509TENS&EMS units (SM9109A, SM9109B)Plexus Yoga, LLC Dba Chirp2024-06-27
K231425Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)Wuxi Jiajian Medical Instrument Co., Ltd.2024-03-27
K240292Transcutaneous Electrical Nerve Stimulator (9029SCM)Hong Kong Etech Groups Limited2024-03-25
K232439Electrical Stimulator SystemGymmax Technology Shenzen Co., Ltd.2024-03-21
K231648Muscle StimulatorShenzhen Yiran Intelligent Co., Ltd.2024-03-01

Related GUDID Devices

Primary DIBrandCompanyPublished
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06971292004301AUVONShenzhen Yuwen E-Commerce Co., Ltd.2026-01-21
00850016867407Pixie CupPixie Cup LLC2026-01-09
06971292004295AUVONShenzhen Yuwen E-Commerce Co., Ltd.2025-12-17
00810093080786PainPod Hi-Dow International Incorporated2025-12-09
00810093080793PainPod Hi-Dow International Incorporated2025-12-09
04719871185605iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.2025-12-03
04719871186039EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.2025-12-03
16978452680020EPULSEShenzhen Jiantuo Electronics Co., Ltd2025-12-01
16978452680037KONGZEEShenzhen Jiantuo Electronics Co., Ltd2025-12-01
06971292004127AUVONShenzhen Yuwen E-Commerce Co., Ltd.2025-09-22
10850073128197AVCOOADP HEALTH LIMITED2025-09-19
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06971292004103AUVONShenzhen Yuwen E-Commerce Co., Ltd.2025-09-11
16971292008078AUVONShenzhen Yuwen E-Commerce Co., Ltd.2025-09-02
16970890320681AUVONShenzhen As-Tec Technology Co.,Ltd.2025-08-30
00850073128121AVCOOADP HEALTH LIMITED2025-08-25
10850073128135AVCOOADP HEALTH LIMITED2025-08-25
06973602730719reajoyTOP-RANK HEALTH CARE CO., LTD.2025-08-21
16978452680013NURSALShenzhen Jiantuo Electronics Co., Ltd2025-08-21
06971292008064AUVONShenzhen Yuwen E-Commerce Co., Ltd.2025-08-12
16971712724717UnimedHong Qiangxing (Shen Zhen) Electronics Limited2025-08-11
00851221006803Quell 2.0NEUROMETRIX, INC.2025-08-01
16978146200107SinrelSHENZHEN SINREL TECH LTD2025-07-14
04251784906101HealyHealy GmbH2025-07-10
16970890320667AUVONShenzhen As-Tec Technology Co.,Ltd.2025-01-16
06971712722082CriterionHong Qiangxing (Shen Zhen) Electronics Limited2022-08-03