FDA Enforcement
Class II
Terminated
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
Recall: Z-2183-2012
·
Reported August 22, 2012
Enforcement
- Recall Number
- Z-2183-2012
- Event ID
- 61855
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- JK Products & Services, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 22, 2012
- Initiation Date
- May 7, 2012
- Classification Date
- August 10, 2012
- Termination Date
- January 7, 2015
- Address
- 1 Walter Kratz Dr, Jonesboro, AR, 72401-0609, United States
Description
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
Reason
The Beauty Angel was marketed without a 510k.
Code Info
All Beauty Angel Models and Serial Numbers Part Numbers 80000904301 and 8001110201.
Distribution
Worldwide Distribution - USA (nationwide) and Canada
Quantity
598 units