Therasage Corporation
Boca Raton, FL, US
Therasage Corporation appears in FDA device records in Boca Raton, FL. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Therasage Corporation in 2012.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1541-2015 | 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 . | Product distributed without 510(k) approval | Class II | Terminated | |
| Z-1540-2015 | 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 . | Product distributed without 510(k) approval | Class II | Terminated | |
| Z-1539-2015 | 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 . | Product distributed without 510(k) approval | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain