Pure Flow External Counter-Pulsation Device

Pure Flow External Counter-Pulsation Device is an FDA 510(k)-cleared medical device (K173483) manufactured by Xtreem Pulse, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2018. Regulation: 8.