NUH
- Product code
- NUH
- Device name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5890
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 229
FDA classification definition
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
510(k) clearances, last 3 years (42)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260412 | 2026-06-26 | Shenzhen Dongdixin Technology Co., Ltd | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | — |
| K260425 | 2026-06-16 | Hivox Biotek, Inc. | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | — |
| K253896 | 2026-03-04 | Globalcare Medical Technology Co., Ltd | TENS/EMS device (GUSE01) | |
| K253305 | 2025-12-31 | Shenzhen Jiantuo Electronics Co., Ltd. | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, J | — |
| K253740 | 2025-12-23 | Hong Qiangxing (Shenzhen) Electronics | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | — |
| K251958 | 2025-12-23 | Dynapulse Medical | VEINOPLUS Back | |
| K252688 | 2025-11-24 | Bozhou Rongjian Medical Appliance Co., | Transcutaneous Electrical Nerve Stimulator (RJTENS-2 | |
| K251856 | 2025-11-21 | Everyway Medical Instruments Co.,Ltd | Li-Battery Powered OTC TENS/EMS Combination Stimulat | |
| K243131 | 2025-11-07 | Sigma Biomedical | Triathlon Pro | |
| K251429 | 2025-08-28 | Changsha Anxiang Medical Technology Co | OTC 4-Channel Rechargeable TENS Unit | — |
| K250784 | 2025-08-21 | Shenzhen Yicai Health Technology Co., | Transcutaneous Electrical Nerve Stimulator ( K6133/ | — |
| K251187 | 2025-07-28 | Changsha Anxiang Medical Technology Co | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | — |
| K243856 | 2025-05-29 | Shenzhen Astec Technology Co., Ltd. | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS | — |
| K250360 | 2025-05-11 | Shenzhen Jiantuo Electronics Co., Ltd. | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,J | — |
| K250053 | 2025-05-09 | Shenzhen Jiantuo Electronics Co., Ltd. | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, J | — |
| K243613 | 2025-04-09 | Transtimulation Research, Inc. | Patch-TEA (Model TRI-21) | |
| K250033 | 2025-04-07 | Guangzhou Pinzhi Medical Technology Co | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | — |
| K242460 | 2025-04-02 | Progenix, LLC | Progenix Select Stim | |
| K242815 | 2024-12-17 | Hivox Biotek, Inc. | POCKET TENS (EP-300) | |
| K243334 | 2024-11-22 | Xf Agencija Limited | Nooro Body & Foot Stimulator (SM9141, SM9142) | — |
| K242332 | 2024-11-05 | Shenzhen Kentro Medical Electronics Co | Transcutaneous Electronic Nerve Stimulator (KTR-230 | — |
| K242567 | 2024-11-04 | Changsha Anxiang Medical Technology Co | Muscle and Nerve Stimulator TENS & EMS (TP2208), Mus | — |
| K233054 | 2024-10-18 | Well-Life Healthcare Limited | Well-Life Pain Relief (Menstrual Plus) Electrical St | |
| K241678 | 2024-09-09 | Shenzhen Minghuangda Electronics Co., | TENS & EMS Stimulator (MHD-1083) | |
| K241365 | 2024-08-12 | Pixie Cup, LLC | Pixie Pulse (SM9068) | — |
| K241119 | 2024-07-22 | Shenzhen Yicai Health Technology Co., | Transcutaneous Electrical Nerve Stimulator (K6106) | |
| K233067 | 2024-07-19 | Chongqing Rob Linka Science and Techno | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | — |
| K241509 | 2024-06-27 | Plexus Yoga, LLC Dba Chirp | TENS&EMS units (SM9109A, SM9109B) | — |
| K231425 | 2024-03-27 | Wuxi Jiajian Medical Instrument Co., L | Transcutaneous Electrical Nerve Stimulator (TENS WMP | |
| K240292 | 2024-03-25 | Hong Kong Etech Groups Limited | Transcutaneous Electrical Nerve Stimulator (9029SCM) | |
| K232439 | 2024-03-21 | Gymmax Technology Shenzen Co., Ltd. | Electrical Stimulator System | |
| K233095 | 2024-03-01 | Micro Current Technology, Inc. | S21 OTC Transcutaneous Electrical Nerve Stimulator | — |
| K231648 | 2024-03-01 | Shenzhen Yiran Intelligent Co., Ltd. | Muscle Stimulator | |
| K233784 | 2024-02-23 | Hinge Health, Inc. | ENSO (Model 2) | |
| K233040 | 2024-02-12 | Shenzhen Imdk Medical Technology Co., | EMS/TENS Massager Device | — |
| K233092 | 2024-02-12 | Chongqing Rob Linka Science and Techno | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W | — |
| K231423 | 2024-01-22 | Shenzhen Roundwhale Technology Co. , L | Combo Electrotherapy Device (Models: R-C101C, R-C101 | |
| K233461 | 2024-01-19 | Hi-Dow International, Inc. | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | — |
| K230926 | 2023-12-15 | Tenscare, Ltd. | Ova+ (K-OVAP-USA) | FDA |
| K232517 | 2023-12-08 | Shenzhen Kentro Medical Electronics Co | Transcutaneous Electrical Nerve Stimulator For Pain | — |
| K231569 | 2023-11-03 | Manamed, Inc. | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | |
| K232675 | 2023-10-05 | Hivox Biotek, Inc. | Heating Tens, FT-615 |
Official FDA classification page: NUH
Classification and pathway per current FDA publications. Data from openFDA (CC0).