510(k) · Neurology

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

by Otto Bock Healthcare Products GmbH

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) is an AI-enabled medical device from Otto Bock Healthcare Products GmbH that the U.S. FDA cleared through 510(k) K253256 on April 22, 2026. Its lead review panel is Neurology and its primary product code is GXY (Electrode, Cutaneous).

See also FDA-cleared AI neurology devices in 2026, all FDA AI clearances in 2026, top neurology AI devices.

Key facts

Submission numberK253256
Pathway510(k)
Date of final decision
Company (FDA list)Otto Bock Healthcare Products GmbH
Lead review panelNeurology
Primary product codeGXY — Electrode, Cutaneous
Applicant (openFDA)Otto Bock Healthcare Products GmbH
Applicant locationVienna, AT
Device classClass 2
Regulation number21 CFR 882.1320
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) went through this pathway (K253256).

openFDA lists it as a Class 2 device under 21 CFR 882.1320. Class II devices are moderate risk and are subject to general and special controls.

Product code GXY covers 5 devices on the FDA AI list. By decision date, this device is #5 of 5 under that code. Otto Bock Healthcare Products GmbH has 2 AI-enabled devices on the list, and the Neurology panel accounts for 73 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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