AI devices with FDA product code GXY — Electrode, Cutaneous
Product code GXY (“Electrode, Cutaneous” in openFDA) covers 5 devices on the FDA AI-enabled list, from 4 companies. Most are reviewed by the Neurology panel (5). The most recent decision was myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) on April 22, 2026.
5AI devices
4Companies
2018First decision
2026-04-22Latest decision
Trend: devices per year
2018201920232026
Top companies
All 5 devices, newest first
- myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)Otto Bock Healthcare Products GmbH · Neurology
- Alpha Control Liner System (ACLS)Coapt · Neurology
- Myo PlusOtto Bock Healthcare Products GmbH · Neurology
- COMPLETE CONTROL System Gen2Coapt, LLC · Neurology
- Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC · Neurology