FDA-Device2015-06-03Class II

Elastic Ankle 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.

United Surgical Associates
Hazard

The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

Sold states
Domestic: HI International; None
Affected count
1278
Manufactured in
2235 Pennsylvania St, Fort Wayne, IN, United States
Products
Elastic Ankle 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1664-2015

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