FDA.reportPublic FDA data

Custom-made upper-limb orthosis

Definition
An externally-applied wearable appliance constructed with specific characteristics (e.g., size, shape, material), as prescribed by a healthcare provider for a specified patient (custom-made), intended to support and correct deformities of the arm and/or hand. It may be one of numerous different designs and is typically made of synthetic and textile materials. This is a single-patient reusable device.
GUDID devices
17
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10628634832162Turtlebrace9321-8758 Québec IncElbow Baby 2023-01-16
20628634832077Turtlebrace9321-8758 Québec IncWrist Pediatric with zipper closure2023-01-16
20628634832084Turtlebrace9321-8758 Québec IncWrist Pediatric with velcro closure2023-01-16
20628634832145Turtlebrace9321-8758 Québec IncWrist Pediatric 2023-01-16
20628634832176Turtlebrace9321-8758 Québec IncElbow Pediatric 2023-01-16
30628634832098Turtlebrace9321-8758 Québec IncWrist Adult with zipper closure2023-01-16
30628634832104Turtlebrace9321-8758 Québec IncWrist Adult with velcro closure2023-01-16
30628634832159Turtlebrace9321-8758 Québec IncWrist Adult2023-01-16
30628634832180Turtlebrace9321-8758 Québec IncElbow Adult2023-01-16
80628634832116Turtlebrace9321-8758 Québec IncUniversal Fingers Attachement2023-01-16
80628634832123Turtlebrace9321-8758 Québec IncUniversal Thumb Attachement2023-01-16
80628634832130Turtlebrace9321-8758 Québec IncUniversal Finger2023-01-16
08719327474402AmbroiseAmbroise Holland B.V.WEO2023-09-15
08720299427754AmbroiseAmbroise Holland B.V.Ambroise Triplemode Armorthosis (ATA)2023-09-15
08720299427778AmbroiseAmbroise Holland B.V.W2CO2023-09-15
08720299427785AmbroiseAmbroise Holland B.V.WCO2023-09-15
08720299427792AmbroiseAmbroise Holland B.V.WSO2023-09-15