Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)

Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) is an FDA 510(k)-cleared medical device (K160031) manufactured by Sunrise Medical (Us), LLC. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2016. Regulation: 8.