FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain re...
FDA Recall #Z-1540-2015 — Class II — December 23, 2014
Product Description
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 .
Reason for Recall
Product distributed without 510(k) approval
Recalling Firm
Therasage, LLC. — Boca Raton, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
Code Information
TS5651
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated