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FDA 510(k)

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

K-Number: K253256 · 2026-04-22

ApplicantOtto Bock Healthcare Products GmbH
Decision Date2026-04-22
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) is a medical device manufactured by Otto Bock Healthcare Products GmbH. It received FDA 510(k) clearance on 2026-04-22 under approval number K253256. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)?

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) is a medical device that received FDA 510(k) clearance on 2026-04-22. It is manufactured by Otto Bock Healthcare Products GmbH. The 510(k) number is K253256.

When was myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) approved by the FDA?

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) received FDA 510(k) clearance on 2026-04-22, under approval number K253256.

What company makes myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)?

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) is manufactured by Otto Bock Healthcare Products GmbH.

What is the FDA product code for myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)?

The FDA product code for myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) is GXY.

Other Devices by Otto Bock Healthcare Products GmbH

K191179Myo Plus

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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