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U.S. Department of Health and Human Services

Class 2 Device Recall The Rejuvenator

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  Class 2 Device Recall The Rejuvenator see related information
Date Initiated by Firm August 08, 2014
Date Posted September 30, 2014
Recall Status1 Terminated 3 on August 06, 2015
Recall Number Z-2734-2014
Recall Event ID 69053
Product Classification Chamber, hyperbaric - Product Code CBF
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.
Code Information All Lots, Series and Codes
Recalling Firm/
Manufacturer		 Baro-Therapies, Inc
80 S Geronimo St
Unit 3
Miramar Beach FL 32550-8035
For Additional Information Contact Hollis Risley
850-654-0051
Manufacturer Reason
for Recall		 The firm is distributing the Rejuvenator device without an approved 510(k).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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