# K250153: Neu Platform

- Pathway: 510(k) (Traditional)
- Applicant: Neuhealth Digital, Ltd.
- Decided: Apr 25, 2025 after 94 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.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220820: Parky App, H2o Bilisim Yazilim (2022) Summary page 5.

## Most influential descendants
- K262515: Kneu Platform (V2) (2026), 0 descendants of its own

## Indications for use
The Neu Platform is intended to quantify the kinematics of movement disorder symptoms, including tremor in adults (45 years and older) with mild to moderate Parkinson’s disease.

Source page: https://510kreport.com/device/K250153
Methodology: https://510kreport.com/methodology