BIOSTEP LP

Device typeMechanical-resistance external ankle-foot prosthesis: A mechanical 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 control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media). The device may have various designs and functional features (e.g., SACH, SAFE, partial-foot, energy-storing carbon fibre spring blade type, adjustable heel height, split/sandal toe) for support during a variety of activities.

FDA categoryComponent, External, Limb, Ankle/Foot

Device ID00713980023975

MRI safetyLabeling does not contain MRI Safety Information