K251187 is an FDA 510(k) clearance for the 3 in 1 TENS UNIT (TC1241, TC2241, TS1241). This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Changsha Anxiang Medical Technology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on July 28, 2025, 102 days after receiving the submission on April 17, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5890. Temporary Relief Of Pain Due To Sore/aching Muscles.
| 510(k) Number | K251187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2025 |
| Decision Date | July 28, 2025 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | NUH - Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Temporary Relief Of Pain Due To Sore/aching Muscles |