Device product
Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
Z-1666-2015
Product summary
- Event
- Event 71256
- Status
- Terminated
- Classification
- Class II
- Quantity
- 756
- Official record key
device-enforcement:Z-1666-2015
Official wording
Reason: The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Code information: Product # i-75100 Lot# AK20140801002
Distribution pattern: Domestic: HI International; None
Derived failure modes
-
Unknown
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction