Orthotic insole, custom-made

37 devices · GMDN 62870

Custom-made orthotic insoles are shoe inserts designed to correct foot alignment, relieve pressure on specific areas, or support the arch and heel. They are tailored to an individual’s unique foot structure and prescribed by healthcare professionals to address conditions like plantar fasciitis, flat feet, or post-surgical recovery.

These devices are typically reusable but intended for single-patient use, often crafted from materials like foam, cork, or rubber. Regulation varies by jurisdiction, but they are generally classified based on their intended use and risk level, with compliance requirements tied to manufacturing standards and professional prescription guidelines.

This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.

Devices in this category