Gentherm Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0496-2022Class IIElectri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193November 22, 2021
Z-2092-2021Class IIHemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool orJune 17, 2021