Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal
Device Facts
| Record ID | 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. |
| Product Code | GYD · Neurology |
| Decision Date | Aug 14, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1950 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.
