Device 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 .
Z-1539-2015
Product summary
- Firm
- Therasage, LLC.
- Event
- Event 70737
- Status
- Terminated
- Classification
- Class II
- Quantity
- 0
- Official record key
device-enforcement:Z-1539-2015
Official wording
Reason: Product distributed without 510(k) approval
Code information: TS4544
Distribution pattern: Nationwide Distribution including SD, IL, TX, OR, NY, WI, GA, and CA.
Derived failure modes
-
Unknown
Product distributed without 510(k) approval