Empatica Health Monitoring Platform for Parkinson's Disease Monitoring +5 more— 510(k) K260374
Substantially EquivalentEmpatica S.r.l.
FDA 510(k) clearance K260374 for Empatica Health Monitoring Platform for Parkinson's Disease Monitoring +5 more, Substantially Equivalent on 2026-08-14. Applicant: Empatica S.r.l.. Device class: 2.
Summary
Empatica's submission lists six names: the Empatica Health Monitoring Platform for Parkinson's Disease Monitoring, EmbracePlus, EmbraceMini, Empatica Care, PKG Monitor by Empatica, and Care Portal. The product code is GYD, tremor transducers.
Class II, 21 CFR 882.1950. Neurology is both the classification panel and the review panel, and it was a Traditional 510(k).
Empatica filed from Milan, Italy. The decision came 190 calendar days after FDA received it (February 5 to August 14, 2026), and it was substantially equivalent.
Clearance details
- Device name as filed
- Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal
- Applicant
- Empatica S.r.l.
- Product code
- Product code GYD
- Device class
- Class 2
- Regulation
- 21 CFR 882.1950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milan, IT
Recent devices under product code GYD
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