The following data is part of a premarket notification filed by Myndtec Inc. with the FDA for Myndmove 2.0.
| Device ID | K212149 |
| 510k Number | K212149 |
| Device Name: | MyndMove 2.0 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | MyndTec Inc. 1900 Minnesota Court Suite 122 Mississauga, CA |
| Contact | Yesmil Pena |
| Correspondent | Yesmil Pena MyndTec Inc. 1900 Minnesota Court Suite 122 Mississauga, CA |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-09 |
| Decision Date | 2022-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00692520202004 | K212149 | 000 |