Innercool Therapies, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Innercool Therapies, Inc. makes
Innercool Therapies, Inc. manufactures the CELSIUS CONTROL SYSTEM, a device designed for targeted hypothermia therapy to regulate body temperature during critical medical procedures.
The CELSIUS CONTROL SYSTEM is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Celsius Control System Ref K022366
Regimes: 510(k) Registry: 510(k)Celsius Control System Ref K033623
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Innercool Therapies, Inc. have in the registry?
The registry currently lists 2 devices for Innercool Therapies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innercool Therapies, Inc.'s devices?
Among its 2 most recently registered devices, Innercool Therapies, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Innercool Therapies, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Innercool Therapies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Innercool Therapies, Inc. in the registry?
The most recently registered devices listed for Innercool Therapies, Inc. include CELSIUS CONTROL SYSTEM.