K222863 is an FDA 510(k) clearance for the Garment Electrodes. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Tone-A-Matic International, Inc. (Mississauga, CA). The FDA issued a Cleared decision on February 1, 2023, 132 days after receiving the submission on September 22, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K222863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2022 |
| Decision Date | February 01, 2023 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |