K200942 is an FDA 510(k) clearance for the Well-Life Garment Electrodes (GM Series). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Well-Life Healthcare Limited (New Taipei City, TW). The FDA issued a Cleared decision on June 1, 2021, 419 days after receiving the submission on April 8, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K200942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2020 |
| Decision Date | June 01, 2021 |
| Days to Decision | 419 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 |