NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter Class II
FDA product code NUH covers "Stimulator, Nerve, Transcutaneous, Over-The-Counter", a Class II medical device regulated under 21 CFR 882.5890. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260412 | shenzhen dongdixin technology co | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | June 26, 2026 |
| K260425 | hivox biotek | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | June 16, 2026 |
| 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 |