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Barcode (UDI): 4032767133314
Catalog No: 3R41
Product Type: Medical Device
GMDN: Mechanical-resistance external knee prosthesis (64718)
Regulation: 2017/745
Description: A device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for device stance/swing control is based on media-free mechanical resistance (i.e., mechanical friction/spring-actuation with no fluid or gas operating media). The device may have various designs and functional features (e.g., hinge-type, spring-control, monocentric or polycentric, semi-automatic or manual lock/brake) for support during a variety of activities.