FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2734-2014
- Recalling firm
- Baro-Therapies, Inc
- 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.
- Status
- Terminated
- Initiated
- 2014-08-08
- Posted
- 2014-09-30
- Terminated
- 2015-08-06
- 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.
- Lot, serial or model codes
- All Lots, Series and Codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBF
- Firm FEI
- 3009829568
- Firm city
- Miramar Beach
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28