Therasage, LLC. recalls FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion ther…

Recall date

December 23, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1539-2015

FDA classification

Class II

Brand / firm

Therasage, LLC.

Sold / distributed

Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.

Why it was recalled

Product distributed without 510(k) approval

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 .