PolarCap System

Primary DI

07350128680008

Basic UDI-DI Code

735012868001AN

Reference

PC10-001

Device Types

Single use

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

PolarCool AB

The PolarCap System consists of an energy control unit (SmallCool) to which a soft and tight-fitting patient cooling pad covering the scalp and the neck is connected (PolarCap). The SmallCool pushes temperature-controlled PC Coolant through the PolarCap. This results in heat exchange between the PolarCap and the patient’s skin. PC Coolant temperature is controlled by a thermostat and its temperature probe. The PolarCap System maintains a controlled PC Coolant temperature during the entire treatment period. Any deviations from the default temperature are automatically adjusted by the system.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).