K243339 is an FDA 510(k) clearance for the WiTOF. This device is classified as a Stimulator, Nerve, Peripheral, Electric (Class II - Special Controls, product code KOI).
Submitted by Idmed (Marseille, FR). The FDA issued a Cleared decision on June 23, 2025, 241 days after receiving the submission on October 25, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K243339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 2024 |
| Decision Date | June 23, 2025 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | KOI - Stimulator, Nerve, Peripheral, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |