K172919 is an FDA 510(k) clearance for the EV-804 OTC Pain Relief TENS. 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 (New Taipei City, TW). The FDA issued a Cleared decision on April 19, 2018, 206 days after receiving the submission on September 25, 2017.
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 | K172919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2017 |
| Decision Date | April 19, 2018 |
| Days to Decision | 206 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 |