K223825 is an FDA 510(k) clearance for the Tens & Ems Device. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Shenzhen Jian Feng Electronic Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 9, 2023, 139 days after receiving the submission on December 21, 2022.
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 | K223825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2022 |
| Decision Date | May 09, 2023 |
| Days to Decision | 139 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 |