Neurology
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
Otto Bock Healthcare Products GmbH
FDA
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K253256
- Decision date
- April 2026
- FDA panel
- Neurology
- Product code
- GXY
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA 510k
K253256
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.