# K260374: Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal

- Pathway: 510(k) (Traditional)
- Applicant: Empatica S.r.l.
- Decided: Aug 14, 2026 after 190 days
- Product code: GYD (Transducer, Tremor)
- Device class: 2
- Regulation: 21 CFR 882.1950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 41 generations back to K941811 (1994). 427 ancestors in all.
No later device cites it as a predicate yet.
2 of 428 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211887: Personal Kinetigraph (PKG) System Gen 2 Plus, Gkc Manufacturing Pty, Ltd. (2022) Summary page 6.
- K252981: EmbraceMini, Empatica S.r.l. (2025) Summary page 6.
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal, Empatica S.r.l. (2023) Summary page 6.

## Indications for use
The Empatica Health Monitoring Platform for Parkinson’s Disease Monitoring is a wearable device and paired mobile and cloud-based software platform intended to quantify kinematics of movement tremor, bradykinesia, and dyskinesia. It includes a medication reminder, an event marker and is intended to monitor activity associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age. The product also supports continuous data collection for monitoring the following physiological parameters: ● Physical movement associated with applications in physiological monitoring ● Activity associated with movement during sleep The Empatica Health Monitoring Platform can also be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

Source page: https://510kreport.com/device/K260374
Methodology: https://510kreport.com/methodology