myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)— 510(k) K253256
Substantially EquivalentOtto Bock Healthcare Products GmbH
FDA 510(k) clearance K253256 for myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T), Substantially Equivalent on 2026-04-22. Applicant: Otto Bock Healthcare Products GmbH.
Clearance details
- Applicant
- Otto Bock Healthcare Products GmbH
- Product code
- Code GXY
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vienna, AT
Data sourced from openFDA. This site is unofficial and independent of the FDA.