FAR-Infrared Heat Home Sauna, 2 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 .

Product distributed without 510(k) approval

On January 20, 2015 Therasage sent a notification to its consignees asking them to discard any of the labeling materials that state the following: 1) Use of the sauna allows one to "naturally detoxify." 2) Use of the sauna expels toxins from the body 3) Any reference to an exact amount of calories one uses in an hour when enjoying the benefits of this product 4) Although this product is enhanced with a negative ion environment, we cannot say that the product is enhanced with negative ion therapy 5) Any reference to the maximum infrared absorption available cannot be explicitly stated, as it may vary for each individual person. Customers with questions were instructed to call 888-416-4441 or email [email protected]. For questions regarding this recall call 561-416-9300.