Cool Systems, Inc. (Dba Game Ready)
United StatesFDA applicant, unverified
- Devices
- 2
What Cool Systems, Inc. (Dba Game Ready) makes
Cool Systems, Inc. manufactures cryotherapy devices, including the Med4 Elite and the Game Ready GRPro 2.1 System, designed for rapid tissue cooling and recovery applications.
These products are classified as Class II devices under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Med4 Elite Ref K171685
Regimes: 510(k) Registry: 510(k)Game Ready GRPro 2.1 System Ref K192114
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cool Systems, Inc. (Dba Game Ready) have in the registry?
The registry currently lists 2 devices for Cool Systems, Inc. (Dba Game Ready). Devices recorded under merged duplicate company entries are counted once.
Which registries list Cool Systems, Inc. (Dba Game Ready)'s devices?
Among its 2 most recently registered devices, Cool Systems, Inc. (Dba Game Ready) has devices listed in FDA 510(k) (2 devices).
What risk classes do Cool Systems, Inc. (Dba Game Ready)'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cool Systems, Inc. (Dba Game Ready)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cool Systems, Inc. (Dba Game Ready) in the registry?
The most recently registered devices listed for Cool Systems, Inc. (Dba Game Ready) include Med4 Elite and Game Ready GRPro 2.1 System.