FDA 510(k)

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

N.º K: K253256 · 2026-04-22

SolicitanteOtto Bock Healthcare Products GmbH

Fecha de decisión2026-04-22

Código de productoGXY

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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