K210383 is an FDA 510(k) clearance for the Wrap Accessory Electrodes. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Hi-Dow International, Inc. (Maryland Heights, US). The FDA issued a Cleared decision on November 12, 2021, 276 days after receiving the submission on February 9, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K210383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2021 |
| Decision Date | November 12, 2021 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |