Device Category Dossier

Orthotic insole, custom-made

Device Category Dossier for Orthotic insole, custom-made. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Custom foot orthoses are individually designed and manufactured devices that support, align, and redistribute mechanical forces of the foot and lower limb following podiatric clinical assessment and prescription using patient-specific anatomical data. The devices are worn within footwear in the management of biomechanical and musculoskeletal conditions of the foot and lower limb.