K170564 is an FDA 510(k) clearance for the MyndMove System, MyndMove Functional Electrical Stimulator. 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 August 30, 2017, 184 days after receiving the submission on February 27, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K170564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2017 |
| Decision Date | August 30, 2017 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZI — Stimulator, Neuromuscular, External Functional |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5810 |