# K071050: Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Coolsystems, Inc.
- Decided: Jun 29, 2007 after 77 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951769 (1995). 2 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951769: Cryopress, Grimm Scientific Industries, Inc. (1995) Summary page 1.
- K961855: Polar Care (Model 500/50000), Breg, Inc. (1996) Summary page 1.

## Most influential descendants
- K072620: Game Ready Classic System, Model 550550 (2007), 23 descendants of its own
- 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

## Recalls of this device
- Aug 23, 2011 · Not classified · Z-3210-2011: It was discovered that some Game Ready Professional Therapy System units that were to have been quarantined pending final inspection and testing were inadvertently moved to finished goods inventory an

## Indications for use
The Game Ready System combines cold and compression therapies. It 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 healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

Source page: https://510kreport.com/device/K071050
Methodology: https://510kreport.com/methodology