# K192114: Game Ready GRPro 2.1 System

- Pathway: 510(k) (Traditional)
- Applicant: Cool Systems, Inc. (Dba Game Ready)
- Decided: Oct 29, 2019 after 84 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951769 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072620: Game Ready Classic System, Model 550550, Coolsystems, Inc. (2007) Summary page 5.

## Most influential descendants
- K193079: ICE COMPRESSION FIRST, DUO, & MOOVE Systems (2021), 0 descendants of its own

## Indications for use
The Game Ready GRPro 2.1 System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings or home settings.

Source page: https://510kreport.com/device/K192114
Methodology: https://510kreport.com/methodology