FDA-Device2015-05-06Class II
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 .
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
8 devices
Manufactured in
21000 Boca Rio Rd Ste A21c, Boca Raton, FL, United States
Products
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 .
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1541-2015Don't want to check this manually?
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