ROADRUNNER, PEP THERAPY DEVICE

ROADRUNNER, PEP THERAPY DEVICE is an FDA 510(k)-cleared medical device (K991561) manufactured by Dhd Healthcare Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 9, 1999. Regulation: 8.