# K140086: Personal Kinetigraph (PKG) System

- Pathway: 510(k) (Traditional)
- Applicant: Gkc Manufacturing Pty, Ltd.
- Decided: Aug 22, 2014 after 220 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: 5 generations back to K854030 (1986). 14 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971318: MM-1 Movement Monitor, Axon Instruments, Inc. (1997) Summary page 4.
- K063872: Kinesia, Cleveland Medical Devices, Inc. (2007) Summary page 4.
- K080545: Actitrainer, Actigraph, LLC (2008) Summary page 4.
- K060298: Pill Phone, Vocel (2006) Summary page 4.

## Most influential descendants
- K213519: Rune Labs Tremor Transducer System (2022), 4 descendants of its own
- K220820: Parky App (2022), 3 descendants of its own
- K161717: Personal Kinetigraph (PKG) System (2016), 3 descendants of its own
- K250153: Neu Platform (2025), 1 descendant of its own
- K211887: Personal Kinetigraph (PKG) System Gen 2 Plus (2022), 1 descendant of its own

## Indications for use
The Personal Kinetigraph (PKG) System 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/K140086
Methodology: https://510kreport.com/methodology