Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negat...
FDA Recall #Z-1541-2015 — Class II — December 23, 2014
Product Description
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 .
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
Product Quantity
8 devices
Distribution
Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
Code Information
PS2002
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated