Z-2734-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2014
- Initiation Date
- August 8, 2014
- Termination Date
- August 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
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).
Distribution Pattern
US Nationwide Distribution in the states of FL, GA, MS, TN and CO.
Code Information
All Lots, Series and Codes