# K213519: Rune Labs Tremor Transducer System

- Pathway: 510(k) (Traditional)
- Applicant: Rune Labs, Inc.
- Decided: Jun 10, 2022 after 219 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: 6 generations back to K854030 (1986). 15 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140086: Personal Kinetigraph (PKG) System, Gkc Manufacturing Pty, Ltd. (2014) Summary page 4.

## Most influential descendants
- K220820: Parky App (2022), 3 descendants of its own
- K250153: Neu Platform (2025), 1 descendant of its own
- K262515: Kneu Platform (V2) (2026), 0 descendants of its own
- K253055: Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) (2026), 0 descendants of its own

## Indications for use
The Rune Labs Kinematic System is intended to quantify kinematics of movement disorder symptoms including tremor and dyskinesia, in adults (45 years of age or older) with mild to moderate Parkinson's disease.

Source page: https://510kreport.com/device/K213519
Methodology: https://510kreport.com/methodology