NormaTec PCD-T and PCD-B

NormaTec PCD-T and PCD-B is an FDA 510(k)-cleared medical device (K161346) manufactured by NormaTec Industries, LP. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 14, 2016. Regulation: 8.