# K253055: Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)

- Pathway: 510(k) (Traditional)
- Applicant: Nordic Kinetics AB
- Decided: Jun 17, 2026 after 268 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: 8 generations back to K854030 (1986). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213519: Rune Labs Tremor Transducer System, Rune Labs, Inc. (2022) Summary page 5.
- K220820: Parky App, H2o Bilisim Yazilim (2022) Summary page 5.

## Indications for use
Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch 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/K253055
Methodology: https://510kreport.com/methodology