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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 the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Healthcare Products GmbH. It received FDA 510(k) clearance on 2026-04-22 under 510(k) 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. The listed applicant is Otto Bock Healthcare Products GmbH. The 510(k) number is K253256.

When did myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) receive FDA 510(k) clearance?

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

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

The FDA 510(k) record lists Otto Bock Healthcare Products GmbH as the applicant. This does not by itself establish the device manufacturer.

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 records listing Otto Bock Healthcare Products GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191179Myo Plus

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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