# K211887: Personal Kinetigraph (PKG) System Gen 2 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Gkc Manufacturing Pty, Ltd.
- Decided: Mar 11, 2022 after 263 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: 7 generations back to K854030 (1986). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161717: Personal Kinetigraph (PKG) System, Gkc Manufacturing Pty, Ltd. (2016) Summary page 4.

## Most influential descendants
- K260374: Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal (2026), 0 descendants of its own

## Indications for use
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson’s disease, including 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.

Source page: https://510kreport.com/device/K211887
Methodology: https://510kreport.com/methodology