510(k) Report

Devices descending from K170216

7 later devices reach Flexitouch System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203178Flexitouch Plus SystemTactile Systems Technology, Inc. (Dba Tactile Medical)20205—
+1K193288Koya RippleKoya, Inc.20205—
+2K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical20260—
+2K223228DayspringKoya Medical, Inc.20241—
+2K210885DayspringKoya Medical, Inc.20214—
+3K222823AeroDVx Arm SystemSun Scientific, Inc.20230—
+3K212287Dayspring LiteKoya Medical, Inc.20210—