Alpha Control Liner System (ACLS) is an AI-enabled medical device from Coapt, listed by FDA (510(k), K223738) with a decision date of 2023-01-11. Review panel: Neurology.
| FDA submission number | K223738 |
|---|---|
| Pathway | 510(k) |
| Company | Coapt |
| Review panel (specialty) | Neurology |
| FDA decision date | 2023-01-11 |
| Decision | Substantially Equivalent |
| Product code | GXY |
| Classification | Electrode, Cutaneous |
| Device class | 2 |
| Regulation number | 882.1320 |
| Review time (calendar days) | 28 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.