Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890) → NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter # NUH · Stimulator, Nerve, Transcutaneous, Over-The-Counter _Neurology · 21 CFR 882.5890 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH ## Overview - **Product Code:** NUH - **Device Name:** Stimulator, Nerve, Transcutaneous, Over-The-Counter - **Regulation:** [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K253896.md) | TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. | Mar 4, 2026 | SESE | | [K253305](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K253305.md) | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | Shenzhen Jiantuo Electronics Co., Ltd. | Dec 31, 2025 | SESE | | [K253740](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K253740.md) | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited | Dec 23, 2025 | SESE | | [K251958](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K251958.md) | VEINOPLUS Back | Dynapulse Medical | Dec 23, 2025 | SESE | | [K252688](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K252688.md) | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | Nov 24, 2025 | SESE | | [K251856](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K251856.md) | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | Everyway Medical Instruments Co.,Ltd | Nov 21, 2025 | SESE | | [K243131](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K243131.md) | Triathlon Pro | Sigma Biomedical | Nov 7, 2025 | SESE | | [K251429](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K251429.md) | OTC 4-Channel Rechargeable TENS Unit | Changsha Anxiang Medical Technology Co., Ltd. | Aug 28, 2025 | SESE | | [K250784](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K250784.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K251187.md) | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Changsha Anxiang Medical Technology Co., Ltd. | Jul 28, 2025 | SESE | | [K243856](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K243856.md) | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) | Shenzhen Astec Technology Co., Ltd. | May 29, 2025 | SESE | | [K250360](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K250360.md) | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | Shenzhen Jiantuo Electronics Co., Ltd. | May 11, 2025 | SESE | | [K250053](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K250053.md) | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd. | May 9, 2025 | SESE | | [K243613](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K243613.md) | Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. | Apr 9, 2025 | SESE | | [K250033](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K250033.md) | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | Guangzhou Pinzhi Medical Technology Co., Ltd. | Apr 7, 2025 | SESE | | [K242460](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K242460.md) | Progenix Select Stim | Progenix, LLC | Apr 2, 2025 | SESE | | [K242815](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K242815.md) | POCKET TENS (EP-300) | Hivox Biotek, Inc. | Dec 17, 2024 | SESE | | [K243334](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K243334.md) | Nooro Body & Foot Stimulator (SM9141, SM9142) | Xf Agencija Limited | Nov 22, 2024 | SESE | | [K242332](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K242332.md) | 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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH/K242567.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NUH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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