Device typeLower-limb orthosis ankle/foot component, mechanical-resistance: A non-powered prefabricated (non-customized) component of an externally applied and wearable lower-limb appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct deformities/injuries (e.g., paralysis) or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It is intended to provide motion control functionality through a media-free mechanical resistance mechanism [i.e., spring-actuation with no fluid or gas operating media]. This is a reusable device.
FDA categorySplint, extremity, non-inflatable, external, non-sterile
Device ID00609271769458
Catalog numberFXS4
Single useYes
MRI safetyLabeling does not contain MRI Safety Information