K260374
- 510(k) number
- K260374
- Device name
- Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal
- Applicant
- Empatica S.r.l. IT
- Product code
- GYD — Transducer, Tremor
- Decision date
- 2026-08-14
- Date received
- 2026-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K260374.pdf
Official FDA record: K260374
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.