K253256
- 510(k) number
- K253256
- Device name
- myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
- Applicant
- Otto Bock Healthcare Products GmbH AT
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2026-04-22
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253256.pdf
Official FDA record: K253256
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.