K201335 is an FDA 510(k) clearance for the Li-Battery powered OTC TENS/EMS Combination Stimulator. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Everyway Medical Instruments Co.,Ltd (Shenkeng District, New Taipei City, TW). The FDA issued a Cleared decision on October 24, 2020, 157 days after receiving the submission on May 20, 2020.
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 | K201335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2020 |
| Decision Date | October 24, 2020 |
| Days to Decision | 157 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 |