NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter Class II
Classification Details
- Product Code
- NUH
- Device Class
- Class II
- Regulation Number
- 882.5890
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253896 | globalcare medical technology co | TENS/EMS device (GUSE01) | March 4, 2026 |
| K253305 | shenzhen jiantuo electronics co | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | December 31, 2025 |
| K251958 | dynapulse medical | VEINOPLUS Back | December 23, 2025 |
| K253740 | hong qiangxing (shenzhen) electronics limited | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | December 23, 2025 |
| K252688 | bozhou rongjian medical appliance co | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | November 24, 2025 |
| K251856 | everyway medical instruments co | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 | November 21, 2025 |
| K243131 | sigma biomedical | Triathlon Pro | November 7, 2025 |
| K251429 | changsha anxiang medical technology co | OTC 4-Channel Rechargeable TENS Unit | August 28, 2025 |
| K250784 | shenzhen yicai health technology co | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ | August 21, 2025 |
| K251187 | changsha anxiang medical technology co | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | July 28, 2025 |
| K243856 | shenzhen astec technology co | TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E, | May 29, 2025 |
| K250360 | shenzhen jiantuo electronics co | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | May 11, 2025 |
| K250053 | shenzhen jiantuo electronics co | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | May 9, 2025 |
| K243613 | transtimulation research | Patch-TEA (Model TRI-21) | April 9, 2025 |
| K250033 | guangzhou pinzhi medical technology co | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | April 7, 2025 |
| K242460 | progenix | Progenix Select Stim | April 2, 2025 |
| K242815 | hivox biotek | POCKET TENS (EP-300) | December 17, 2024 |
| K243334 | xf agencija limited | Nooro Body & Foot Stimulator (SM9141, SM9142) | November 22, 2024 |
| K242332 | shenzhen kentro medical electronics co | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2 | November 5, 2024 |
| K242567 | changsha anxiang medical technology co | Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TEN | November 4, 2024 |