K222252 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 Shenzhen Roundwhale Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 19, 2023, 176 days after receiving the submission on July 27, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K222252 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2022 |
| Decision Date | January 19, 2023 |
| Days to Decision | 176 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 |