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Therasage, LLC. recalls Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart
Recalled May 6, 2015 · FDA recall Z-1541-2015 · Therasage
Hazard
Product distributed without 510(k) approval · FDA Class II
Units
8 devices
Sold at
Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
Description
Product distributed without 510(k) approval
Product
Portable FAR Infrared Sauna 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 →