510(k) Report

Devices descending from K172029

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical20181—
+2K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical20180—