CarbonCool® System

The CarbonCool® System is a portable, non-invasive body cooling device designed for temperature reduction in adult patients where clinically indicated, such as in hyperthermic patients. It consists of multiple cooling pads (MPad™) made of thermoplastic polyurethane filled with a proprietary carbon-based cooling medium (HypoCarbon®), held in place by thermal enclosures (Pad Holders), and is used by trained personnel in hospital, clinic, or home settings without requiring power.

CarbonCool uses a Pad Holder design that serves as thermal insulation to optimize heat exchange efficiency and minimize ambient temperature interference, compared to the predicate EMCoolspad which applies directly to skin with an adhesive layer. Both employ the same core cooling technology (HypoCarbon®-filled TPU cells) and require pre-cooling in a freezer; however, CarbonCool stores at -15 to -18°C versus EMCoolspad at 0 to -10°C, and CarbonCool offers optional extended cooling duration via the XTend™ accessory.

ISO 10993-1 (biocompatibility evaluation and testing), ISO 10993-5 (cytotoxicity in vitro), EN ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and delayed hypersensitivity), ASTM F1980-21, ASTM F1886/F1886M-16, ASTM F3039-15, ASTM F2096-11, and ASTM F88/F88M-21 (primary packaging testing). Useable life established at three years.

CarbonCool is substantially equivalent to EMCoolspad because both are non-invasive, passive thermal regulating systems with identical regulatory classification (21 CFR 870.5900, Class II, product code NZE), identical indications for use, identical anatomical site (patient skin surface), and use the same core cooling medium technology. Although CarbonCool introduces a Pad Holder to reduce air gaps and improve heat transfer efficiency (versus direct skin adhesion), this design enhancement does not alter the fundamental mechanism of passive heat removal or create new safety concerns. Biocompatibility and packaging testing confirm the device meets the same material and safety standards as the predicate, and both systems require freezer pre-cooling and manual application/removal for temperature control.