K242326 is an FDA 510(k) clearance for the Wave Electrode (AE02-60). This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Bionit Labs Srl (Soleto, IT). The FDA issued a Cleared decision on January 2, 2025, 149 days after receiving the submission on August 6, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K242326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2024 |
| Decision Date | January 02, 2025 |
| Days to Decision | 149 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 |