5 devices · 4 companies · 2018 to 2026
Product code GXY: Electrode, Cutaneous
5 devices under product code GXY, 2018 to 2026, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Electrode, Cutaneous. 21 CFR 882.1320, Class II. MAUDE held 534 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| myosmart.K253256 · 510(k) | Otto Bock Healthcare Products GmbH | Neurology | database entry | |
| Alpha Control Liner SystemK223738 · 510(k) | Coapt | Neurology | database entry | |
| Myo PlusK191179 · 510(k) | Otto Bock Healthcare Products GmbH | Neurology | database entry | |
| COMPLETE CONTROL System Gen2K191083 · 510(k) | Coapt, LLC | Neurology | database entry | |
| Sense System with IBT ElectrodesK182112 · 510(k) | Infinite Biomedical Technologies, LLC | Neurology | database entry |
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