myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) is an AI-enabled medical device from Otto Bock Healthcare Products GmbH, listed by FDA (510(k), K253256) with a decision date of 2026-04-22. Review panel: Neurology.
| FDA submission number | K253256 |
|---|---|
| Pathway | 510(k) |
| Company | Otto Bock Healthcare Products GmbH |
| Review panel (specialty) | Neurology |
| FDA decision date | 2026-04-22 |
| Decision | Substantially Equivalent |
| Product code | GXY |
| Classification | Electrode, Cutaneous |
| Device class | 2 |
| Regulation number | 882.1320 |
| Review time (calendar days) | 205 |
| 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.