Coolsystems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Coolsystems, Inc. makes
Coolsystems, Inc. manufactures whole-body cryotherapy systems designed for therapeutic cooling, including the Game Ready Professional Therapy System (Model 550100) and the Game Ready Classic System (Model 550550). These devices are intended for reducing inflammation, muscle soreness, and edema through controlled cold exposure treatments.
The company’s portfolio is regulated under FDA Class II devices, with authorisation records maintained through the 510(k) clearance process. The systems are listed in the FDA’s 510(k) registry. Coolsystems, Inc. is based in the United States.
Catalogue
Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy System Ref K071050
Regimes: 510(k) Registry: 510(k)Game Ready Classic System, Model 550550 Ref K072620
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Coolsystems, Inc., initiated on 2011-08-23. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 23 Aug 2011 Z-3210-2011 Unclassified (pre-2012) Terminated 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 and shipped.
Frequently asked questions
How many devices does Coolsystems, Inc. have in the registry?
The registry currently lists 2 devices for Coolsystems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coolsystems, Inc.'s devices?
Among its 2 most recently registered devices, Coolsystems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Coolsystems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Coolsystems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Coolsystems, Inc.?
FDA recall records list 1 recall initiated by Coolsystems, Inc., the most recent initiated on 23 Aug 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Coolsystems, Inc. in the registry?
The most recently registered devices listed for Coolsystems, Inc. include GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM and GAME READY CLASSIC SYSTEM, MODEL 550550.