510(k) Report

Devices descending from K100071

6 later devices reach Emcoolspad through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240933CarbonCool® SystemGlobal Healthcare SG Sdn. Bhd20250—
+1K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemZoll Circulation, Inc.20231—
+1K162523The IQool SystemBraincool AB20172—
+1K121720Welkins Emt/Icu Temperature Managerment SystemWelkins, LLC20120—
+1K120849Hybrid Arcticgel PadMedivance, Inc.20120—
+2K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management…Zoll Circulation, Inc.20250—