Device product
Elastic Knee Support. 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-1665-2015
Product summary
- Event
- Event 71256
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1260
- Official record key
device-enforcement:Z-1665-2015
Official wording
Reason: The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Code information: Product #: i-95103 Elastic Knee Support SM Lot#: AP20140815001 Product#: i-95105 Elastic Knee Support MD Lot#: AP20140815001 Product #: i-95107 Elastic Knee Support LG Lot# AP20140815001
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