K222453 is an FDA 510(k) clearance for the Self-adhesive Electrode. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Guangdong Comytens Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 4, 2022, 81 days after receiving the submission on August 15, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K222453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 81 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 |