Empower

Device typeMechatronic external ankle-foot prosthesis: A battery-powered electromechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion motion control is based on hydraulic, pneumatic, or magnetorheological actuation regulated by a motion-feedback mechanism using electronic sensors and software. It is intended to respond to changes in motion in real-time by continuously sensing motion and temperature and instantly adjusting motion resistance within a single step. Also known as a microprocessor-controlled ankle-foot (MPF), it may have various designs and functional features.

FDA categoryAssembly, Knee/Shank/Ankle/Foot, External

Device ID04064409012220

MRI safetyLabeling does not contain MRI Safety Information