The following data is part of a premarket notification filed by Myndtec Inc with the FDA for Myndmove System, Myndmove Functional Electrical Stimulator.
| Device ID | K170564 |
| 510k Number | K170564 |
| Device Name: | MyndMove System, MyndMove Functional Electrical Stimulator |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | MyndTec Inc 2233 Argentia Road Suite 307 Mississauga, CA L5n 2x7 |
| Contact | Alexa Granger |
| Correspondent | Alexa Granger MyndTec Inc 2233 Argentia Road Suite 307 Mississauga, CA L5n 2x7 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-27 |
| Decision Date | 2017-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00692520202769 | K170564 | 000 |
| 00692520001577 | K170564 | 000 |
| 00692520001669 | K170564 | 000 |
| 00692520001676 | K170564 | 000 |
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| 00692520003038 | K170564 | 000 |
| 00692520003045 | K170564 | 000 |
| 00692520101659 | K170564 | 000 |
| 00692520001454 | K170564 | 000 |
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| 00692520001270 | K170564 | 000 |
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| 00692520001201 | K170564 | 000 |
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| 00692520001232 | K170564 | 000 |
| 00692520001249 | K170564 | 000 |
| 00692520001256 | K170564 | 000 |
| 00692520001263 | K170564 | 000 |
| 00692520102007 | K170564 | 000 |
| 06925209001037 | K170564 | 000 |
| 06925209001204 | K170564 | 000 |
| 06925209001662 | K170564 | 000 |
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| 06925209102000 | K170564 | 000 |