Therasage, LLC.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1540-2015Class IIFAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relieDecember 23, 2014
Z-1539-2015Class IIFAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relieDecember 23, 2014
Z-1541-2015Class IIPortable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, NegativeDecember 23, 2014