Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal is an AI-enabled medical device from Empatica S.R.L., listed by FDA (510(k), K242737) with a decision date of 2025-06-06. Review panel: Cardiovascular.
| FDA submission number | K242737 |
|---|---|
| Pathway | 510(k) |
| Company | Empatica S.R.L. |
| Review panel (specialty) | Cardiovascular |
| FDA decision date | 2025-06-06 |
| Decision | Substantially Equivalent |
| Product code | MWI |
| Classification | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | 2 |
| Regulation number | 870.2300 |
| Review time (calendar days) | 268 |
| Applicant country | IT |
Official FDA database record · FDA AI-enabled device list
All Cardiovascular AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.