K212377 is an FDA 510(k) clearance for the Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Ningbo Medkinetic Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on April 15, 2022, 256 days after receiving the submission on August 2, 2021.
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 | K212377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2021 |
| Decision Date | April 15, 2022 |
| Days to Decision | 256 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 |