Comfortrac Systems
Country not established
- Devices
- 2
What Comfortrac Systems makes
Comfortrac Systems manufactures bi-phasic pressure-relieving mattresses (CT90, CT100) and a tabletop model (CT-1000) designed for patient support in clinical settings, reducing pressure injuries through alternating pressure distribution.
These devices are regulated under FDA’s 510(k) pathway as Class I (CT-1000) and Class II (bi-phasic models), with listings maintained in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Comfortrac, CT90 & CT100 Bi-Phasics Ref K892669
Regimes: 510(k) Registry: 510(k)Comfortrac Table Model Ct-1000 Ref K901971
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Comfortrac Systems have in the registry?
The registry currently lists 2 devices for Comfortrac Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Comfortrac Systems's devices?
Among its 2 most recently registered devices, Comfortrac Systems has devices listed in FDA 510(k) (2 devices).
What risk classes do Comfortrac Systems's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Comfortrac Systems's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Comfortrac Systems in the registry?
The most recently registered devices listed for Comfortrac Systems include COMFORTRAC, CT90 & CT100 BI-PHASICS and COMFORTRAC TABLE MODEL CT-1000.