NormaTec Pulse and NormaTec Pulse Pro

NormaTec Pulse and NormaTec Pulse Pro is an FDA 510(k)-cleared medical device (K160608) manufactured by NormaTec Industries, LP. 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 April 12, 2016. Regulation: 8.