K203158 is an FDA 510(k) clearance for the BioWave BioWraps. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Biowave Corporation (Norwalk, US). The FDA issued a Cleared decision on July 8, 2021, 259 days after receiving the submission on October 22, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K203158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2020 |
| Decision Date | July 08, 2021 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |