Z-2734-2014Class II

The Rejuvenator Chamber manufactured by Baro-Therapies, Inc

Name: Z-2734-2014 The Rejuvenator Chamber manufactured by Baro-Therapies, Inc
Creator: Baro-Therapies, Inc
Published: 2014-08-08
License: https://open.fda.gov/license/

Baro-Therapies, Inc / initiated 2014-08-08 / Terminated

FDA source

Baro-Therapies, Inc began a recall of The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the... on 2014-08-08. FDA classified it as Class II and gives the reason as "The firm is distributing the Rejuvenator device without an approved 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2734-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-08
Posted: 2014-09-30
Terminated: 2015-08-06
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.
Product code: CBF Chamber, Hyperbaric
Reason for recall: The firm is distributing the Rejuvenator device without an approved 510(k).
FDA 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 in commerce: 10
Distribution: US Nationwide Distribution in the states of FL, GA, MS, TN and CO.
Product codes and lots: All Lots, Series and Codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2734-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2734-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-30

Product code CBF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)