FDA Enforcement
Class II
Terminated
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: Z-2734-2014
·
Reported October 8, 2014
Enforcement
- Recall Number
- Z-2734-2014
- Event ID
- 69053
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Baro-Therapies, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 8, 2014
- Initiation Date
- August 8, 2014
- Classification Date
- September 30, 2014
- Termination Date
- August 6, 2015
- Address
- 80 S Geronimo St, Unit 3, Miramar Beach, FL, 32550-8035, United States
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
The firm is distributing the Rejuvenator device without an approved 510(k).
Code Info
All Lots, Series and Codes
Distribution
US Nationwide Distribution in the states of FL, GA, MS, TN and CO.
Quantity
10