Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) is an FDA 510(k)-cleared medical device (K233362) manufactured by Pelvital USA, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 2023. Regulation: 8.