INSTITUTO DE INVESTIGACION EN ORTOPEDIA AVANZADA SOCIEDAD LIMITADA.
Model
PODOACTIVA-US
Device description
Orthopedic and personalized Podoactiva insoles are classified as Class I medical devices intended to prevent and treat various foot-related pathologies. These insoles are custom-made for each patient. They comprise an insole body created through 3D printing, following the prior capture of a virtual mold of the foot using a scanner. This process enables the design of an optimal and personalized treatment plan for the patient. Subsequently, the insole body is covered with a lining to enhance comfort and achieve a polished finish.These insoles are recommended as a treatment option with a medical prescription for individuals dealing with various foot pathologies or related issues such as injuries, discomfort from an irregular foot structure, age-related problems, or biomechanical abnormalities affecting the spine, hips, and knees. Therefore, orthopedic custom insoles are designed to correct and alleviate abnormalities in the arch of the foot, ultimately improving one's gait and helping to prevent injuries.
A shoe insert intended to provide supplemental support for the sole, arch, and/or heel of the foot and specifically produced to meet an individual's special requirements, having been prescribed by a relevant healthcare professional. It is made of various materials (e.g., cork, rubber, foam, textile) and may be of modular design by assembly of various pre-made components. This is a reusable device intended for single-patient use.
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