Device product
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.
Z-2734-2014
Product summary
- Event
- Event 69053
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-2734-2014
Official wording
Reason: The firm is distributing the Rejuvenator device without an approved 510(k).
Code information: All Lots, Series and Codes
Distribution pattern: US Nationwide Distribution in the states of FL, GA, MS, TN and CO.
Derived failure modes
-
Unknown
The firm is distributing the Rejuvenator device without an approved 510(k).