510(k) Report

Devices descending from K212655

2 later devices reach Flyte through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.20231—
+2K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.20240—