# K072620: Game Ready Classic System, Model 550550

- Pathway: 510(k) (Traditional)
- Applicant: Coolsystems, Inc.
- Decided: Oct 31, 2007 after 44 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: 2 generations back to K951769 (1995). 3 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071050: Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy System, Coolsystems, Inc. (2007) Summary page 1.

## Most influential descendants
- K171685: Med4 Elite (2017), 21 descendants of its own
- K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (2018), 12 descendants of its own
- K190854: Therm-X (2019), 11 descendants of its own
- K193550: Therm-X (2020), 10 descendants of its own
- K223729: FLOWpresso (2023), 3 descendants of its own

## Indications for use
The Game Ready Classic 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/K072620
Methodology: https://510kreport.com/methodology