INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM is an FDA 510(k)-cleared medical device (K080908) manufactured by Innercool Therapies, Inc.- A Delaware Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 2008. Regulation: 8.