Home / Recalls / Therasage, LLC. / Z-1539-2015

Z-1539-2015 Class II Terminated

Recalled by Therasage, LLC. — Boca Raton, FL

Recall Details

Product Type
Devices
Report Date
May 6, 2015
Initiation Date
December 23, 2014
Termination Date
August 6, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
0

Product Description

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 .

Reason for Recall

Product distributed without 510(k) approval

Distribution Pattern

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

Code Information

TS4544

Other recalls by Therasage, LLC.

  • Z-1540-2015 Class II — FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited t (December 23, 2014)
  • Z-1541-2015 Class II — Portable FAR Infrared Sauna Indications including, but not limited to Natural p (December 23, 2014)