Custom-made upper-limb orthosis

A custom-made upper-limb orthosis is an externally worn device designed specifically for an individual patient to support, align, or correct deformities of the arm, wrist, or hand. It is fabricated based on a healthcare provider’s prescription to match the patient’s unique anatomy and therapeutic needs, using materials such as plastics, textiles, or composites.

As a single-patient reusable device, it is intended for repeated use by the same individual over time. Regulatory oversight focuses on the manufacturing process and clinical suitability rather than mass production, with requirements varying by jurisdiction but generally emphasizing patient-specific design and safety in use.