K210223 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Top-Rank Health Care Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on December 15, 2021, 321 days after receiving the submission on January 28, 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 | K210223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2021 |
| Decision Date | December 15, 2021 |
| Days to Decision | 321 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| 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 |