K253740 is an FDA 510(k) clearance for the TENS&EMS (HZ9151B, HZ9151C, HZ9151D). This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2025, 29 days after receiving the submission on November 24, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890. Temporary Relief Of Pain Due To Sore/aching Muscles.
| 510(k) Number | K253740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| 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 |