FDA-Device2015-05-06Class II

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 .

Therasage, LLC.
Hazard

Product distributed without 510(k) approval

Sold states
Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
Affected count
0
Manufactured in
21000 Boca Rio Rd Ste A21c, Boca Raton, FL, United States
Products
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 .

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1540-2015

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