# FDA 510(k) cleared: Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal

> fda · VERIFIED · 2026-08-14

Applicant: Empatica S.r.l. · Substantially Equivalent

- Company: Empatica S.r.l.
- Sector: neurotech
- Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260374

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.