510(k) K253256 ยท GXY Electrode, Cutaneous
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
| Applicant | Otto Bock Healthcare Products GmbH, Vienna, AT |
| Decision | Substantially Equivalent, Apr 22, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253256
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.