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. Device class: 2.
Summary
Otto Bock Healthcare Products' record names four items: myosmart. (13E522), myosmart.cuff (757M20-2), connectgrip. (560X27-1), and a myosmart trial kit (642V64=T). All are filed under product code GXY (Electrode, Cutaneous).
Class II, 21 CFR 882.1320. Neurology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Otto Bock Healthcare Products filed from Vienna, Austria. The record shows 205 calendar days from receipt to decision (September 29, 2025 to April 22, 2026).
Clearance details
- Applicant
- Otto Bock Healthcare Products GmbH
- Product code
- Product code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vienna, AT
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