K202866 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. (Baoan District, Shenzhen City, CN). The FDA issued a Cleared decision on May 19, 2021, 233 days after receiving the submission on September 28, 2020.
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 | K202866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2020 |
| Decision Date | May 19, 2021 |
| Days to Decision | 233 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 |