Recall Z-2734-2014— Baro-Therapies, Inc
Class II · Terminated
Class II FDA medical device recall by Baro-Therapies, Inc, initiated 2014-08-08, terminated 2015-08-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The firm is distributing the Rejuvenator device without an approved 510(k)..
- Recalling firm
- Baro-Therapies, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-08
- Terminated
- 2015-08-06
- Firm location
- Miramar Beach, FL, United States
Product description
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.
Reason for recall
The firm is distributing the Rejuvenator device without an approved 510(k).
Data sourced from openFDA. This site is unofficial and independent of the FDA.