Is Empatica Parkinson's Monitoring (PKG Monitor) FDA approved or cleared?
Yes. Empatica Parkinson's Monitoring (PKG Monitor) by Empatica S.r.l. is named in the FDA register with a 510(k) clearance, first authorised in 2014, latest decision in 2026.
At a glance
| Product | Empatica Parkinson's Monitoring (PKG Monitor) |
|---|---|
| Maker | Empatica S.r.l. |
| Care area | Brain & nerves |
| What it does | Wrist-worn monitoring of Parkinson's disease movement symptoms over several days, combining Empatica's platform with the PKG (Personal KinetiGraph) monitor |
| FDA | 510(k), latest decision 2026 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | empatica.com |
| Status | FDA verified |
| Last checked | 18 October 2026 |
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