Medical Device Manufacturer · US , Concord , CA

Cool Systems, Inc. (Dba Game Ready) - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2017

Recent clearances: Game Ready GRPro 2.1 System, Med4 Elite

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cool Systems, Inc. (Dba Game Ready) Physical Medicine ✕

2 devices

1-2 of 2

Cleared Oct 29, 2019

Game Ready GRPro 2.1 System

Physical Medicine · 84d

Cleared Sep 29, 2017

Physical Medicine · 114d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Jun 03, 2026