Recall Z-2734-2014 ยท CBF Chamber, Hyperbaric
Baro-Therapies, Inc
The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.
| Date | Sep 30, 2014 (initiated Aug 8, 2014) |
| Status | Terminated |
| Reason | The firm is distributing the Rejuvenator device without an approved 510(k). |
| Root cause | No Marketing Application |
| Action | Baro-Therapies issued a Correction Notice letter on August 11, 2014, to all affected customers. The letter stated they have suspended marketing of the device and plans to shut down their website until they receive clearance from the FDA. For questions or concerns contact the firm at (850) 654-0051. |
| Quantity | 10 |
| Distribution | US Nationwide Distribution in the states of FL, GA, MS, TN and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.