Recall Z-1539-2015— Therasage, LLC.
Class II · Terminated
Class II FDA medical device recall by Therasage, LLC., initiated 2014-12-23, terminated 2015-08-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Product distributed without 510(k) approval.
- Recalling firm
- Therasage, LLC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-23
- Terminated
- 2015-08-06
- Firm location
- Boca Raton, FL, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.