# K221772: NeuroRPM

- Pathway: 510(k) (Traditional)
- Applicant: New Touch Digital, Inc.
- Decided: Mar 17, 2023 after 269 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.
No later device cites it as a predicate yet.
0 of 17 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.

## Indications for use
NeuroRPM is intended to quantify movement disorder symptoms during wake periods in adult patients 46 to 85 years of age with Parkinson's disease. These symptoms include tremor, bradykinesia, and dyskinesia. NeuroRPM is intended for clinic and home environments.

Source page: https://510kreport.com/device/K221772
Methodology: https://510kreport.com/methodology