K212149 is an FDA 510(k) clearance for the 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 March 3, 2022, 237 days after receiving the submission on July 9, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K212149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2021 |
| Decision Date | March 03, 2022 |
| Days to Decision | 237 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 |