K233006 is an FDA 510(k) clearance for the MyndMove, MyndMove 2.0. This device is classified as a Stimulator, Neuromuscular, External Functional (Class II - Special Controls, product code GZI).
Submitted by Myndtec, Inc. (Mississauga, CA). The FDA issued a Cleared decision on June 25, 2024, 277 days after receiving the submission on September 22, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K233006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2023 |
| Decision Date | June 25, 2024 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | GZI — Stimulator, Neuromuscular, External Functional |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5810 |