Device typeExternal limb prosthesis finishing component, custom-made: A custom-made cosmetic component of an external upper or lower limb prosthesis designed to provide an aesthetic outer shape and surface to the prosthesis via one of various forms (e.g., foot shell, filler, skin, stocking, glove, limb cover) produced for a specific patient manually, or using computer-based anatomical imaging 3-D printing. It may be made of various materials (e.g., foam, thermoplast, wood, silicone, fibreglass, resin, carbon fibre), and may additionally be designed to protect the prosthesis from external agents (e.g., debris, water splashes, impact forces).
FDA categoryMaterial, External Aesthetic Restoration, Used With Adhesive
Device ID05060483013015
Catalog numberAL10C
MRI safetyLabeling does not contain MRI Safety Information