510(k) Report

Devices descending from K212909

2 later devices reach VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV20231—
+2K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120)…Macromedics BV20250—