K260453 is an FDA 510(k) clearance for the Remote Wave Electrode (AE03-50). 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 March 12, 2026, 29 days after receiving the submission on February 11, 2026.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K260453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2026 |
| Decision Date | March 12, 2026 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |