Invacare TDX SP2-HD with Captain's Seat

Invacare TDX SP2-HD with Captain's Seat is an FDA 510(k)-cleared medical device (K182946) manufactured by Invacare Corporation. 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 10, 2018. Regulation: 8.