Flexitouch System

Flexitouch System is an FDA 510(k)-cleared medical device (K153311) manufactured by Tactile Systems Technology, Inc. (Dba Tactile Medical). This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2016. Regulation: 8.