NUH · Stimulator, Nerve, Transcutaneous, Over-The-Counter
Neurology · 21 CFR 882.5890 · Class 2
Overview
| Product Code | NUH |
|---|---|
| Device Name | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 227)
Showing 20 most recent of 227 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253896 | TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. | Mar 4, 2026 | SESE |
| K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | Shenzhen Jiantuo Electronics Co., Ltd. | Dec 31, 2025 | SESE |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | Dec 23, 2025 | SESE |
| K251958 | VEINOPLUS Back | Dynapulse Medical | Dec 23, 2025 | SESE |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | Nov 24, 2025 | SESE |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | Everyway Medical Instruments Co.,Ltd | Nov 21, 2025 | SESE |
| K243131 | Triathlon Pro | Sigma Biomedical | Nov 7, 2025 | SESE |
| K251429 | OTC 4-Channel Rechargeable TENS Unit | Changsha Anxiang Medical Technology Co., Ltd. | Aug 28, 2025 | SESE |
| K250784 | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) | Shenzhen Yicai Health Technology Co., Ltd. | Aug 21, 2025 | SESE |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Changsha Anxiang Medical Technology Co., Ltd. | Jul 28, 2025 | SESE |
| K243856 | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) | Shenzhen Astec Technology Co., Ltd. | May 29, 2025 | SESE |
| K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | Shenzhen Jiantuo Electronics Co., Ltd. | May 11, 2025 | SESE |
| K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd. | May 9, 2025 | SESE |
| K243613 | Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. | Apr 9, 2025 | SESE |
| K250033 | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | Guangzhou Pinzhi Medical Technology Co., Ltd. | Apr 7, 2025 | SESE |
| K242460 | Progenix Select Stim | Progenix, LLC | Apr 2, 2025 | SESE |
| K242815 | POCKET TENS (EP-300) | Hivox Biotek, Inc. | Dec 17, 2024 | SESE |
| K243334 | Nooro Body & Foot Stimulator (SM9141, SM9142) | Xf Agencija Limited | Nov 22, 2024 | SESE |
| K242332 | Transcutaneous 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. | Nov 5, 2024 | SESE |
| K242567 | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) | Changsha Anxiang Medical Technology Co., Ltd. | Nov 4, 2024 | SESE |
Top Applicants
- Everyway Medical Instruments Co.,Ltd — 14 clearances
- Well-Life Healthcare Limited — 11 clearances
- Hivox Biotek, Inc. — 10 clearances
- Shenzhen Kentro Medical Electronics Co., Ltd. — 9 clearances
- Omron Healthcare, Inc. — 7 clearances
