510(k) Report

Devices descending from K082911

2 later devices reach Smoothcool HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213484SmoothCool HR SystemJeisys Medical, Inc.20221—
+2K223685SmoothCool HR SystemJeisys Medical, Inc.20230—