Temptek, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Temptek, Inc. makes
Temptek, Inc. manufactures medical thermal cooling devices, including portable cooling units like the T-300 Cooler and the T-1000 Therapeutic Cooling Unit, as well as thermal cooling blankets such as the Temptek 5010. These products are designed for controlled hypothermia applications, such as post-resuscitation care and neuroprotection during critical medical events.
The company’s portfolio consists of Class II devices, each authorised through the FDA’s 510(k) clearance process. These devices are listed under the FDA’s regulatory framework and are intended for use in clinical settings requiring precise temperature management. Temptek, Inc. is headquartered in the United States.
Catalogue
T-300 Cooler Ref K945468
Regimes: 510(k) Registry: 510(k)Temptek 5010 Thermal Cooling Blanket Ref K891092
Regimes: 510(k) Registry: 510(k)Temptek T-1000 Therapeutic Cooling Unit Ref K891091
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Temptek, Inc. have in the registry?
The registry currently lists 3 devices for Temptek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Temptek, Inc.'s devices?
Among its 3 most recently registered devices, Temptek, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Temptek, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Temptek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Temptek, Inc. in the registry?
The most recently registered devices listed for Temptek, Inc. include T-300 COOLER, TEMPTEK 5010 THERMAL COOLING BLANKET and TEMPTEK T-1000 THERAPEUTIC COOLING UNIT.