510(k) K260374
K260374 is an FDA 510(k) premarket notification submitted by Empatica S.r.l. for the device "Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal". The FDA issued a decision of Substantially Equivalent on August 14, 2026. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950. Empatica S.r.l. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2026
- Date Received
- February 5, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Tremor
- Device Class
- Class II
- Regulation Number
- 882.1950
- Review Panel
- NE
- Submission Type