510(k) K260374 ยท GYD Transducer, Tremor
Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal
| Applicant | Empatica S.r.l., Milan, IT |
| Decision | Substantially Equivalent, Aug 14, 2026 |
| Received | Feb 5, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260374
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.