Home / Recalls / Medical Devices
Therasage, LLC. recalls FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion ther
Recalled May 6, 2015 · FDA recall Z-1540-2015 · Therasage
Hazard
Product distributed without 510(k) approval · FDA Class II
Units
0
Sold at
Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
Description
Product distributed without 510(k) approval
Product
FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
Manufacturer(s)
Therasage, LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →