K213741 is an FDA 510(k) clearance for the TENS & EMS DEVICE (Model: FM-B2403A). 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 March 8, 2022, 99 days after receiving the submission on November 29, 2021.
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 | K213741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2021 |
| Decision Date | March 08, 2022 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| 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 |