Home » BrainCool Receives 510(k) Clearance for Temperature Regulator
BrainCool Receives 510(k) Clearance for Temperature Regulator
Devices Submissions and Approvals
The FDA granted 510(k) marketing clearance for BrainCool’s IQool Warm System, a temperature regulation device indicated to use thermal regulation to cool and rewarm adult patients when clinically indicated.
The system uses non-stick adhesive pads prefilled with a non-toxic bacteriostatic cooling agent that are attached to an automated temperature control unit.
The device is intended for temperature management focused on the head/neck, thigh and torso, allowing the adjustment of patient temperature in different settings.