Pulse 2.0, Pulse Pro 2.0

Pulse 2.0, Pulse Pro 2.0 is an FDA 510(k)-cleared medical device (K183169) 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 December 26, 2018. Regulation: 8.