Myo Plus is an AI-enabled medical device from Otto Bock Healthcare Products GmbH, listed by FDA (510(k), K191179) with a decision date of 2019-09-04. Review panel: Neurology.
| FDA submission number | K191179 |
|---|---|
| Pathway | 510(k) |
| Company | Otto Bock Healthcare Products GmbH |
| Review panel (specialty) | Neurology |
| FDA decision date | 2019-09-04 |
| Decision | Substantially Equivalent |
| Product code | GXY |
| Classification | Electrode, Cutaneous |
| Device class | 2 |
| Regulation number | 882.1320 |
| Review time (calendar days) | 125 |
| Applicant country | AT |
Official FDA database record · FDA AI-enabled device list
All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.