Becker Orthopedic Appliance Company

Becker Orthopedic Appliance Company specializes in orthopedic footplates, leather straps for orthotic devices, and torsion attachments for ankle-foot orthoses (AFOs) and knee-ankle-foot orthoses (KAFOs). Their product line includes customizable kits for right and left limbs, such as the Flat Footplate 3B76 Kit, as well as modular components like proximal attachments for AFOs and KAFOs. These devices are designed to support and correct limb alignment or mobility issues.

The company is based in the United States. While the exact location isn’t specified, its manufacturing and operations align with U.S. regulatory standards for orthopedic appliances, ensuring compliance with applicable domestic and international requirements.

Becker Orthopedic Appliance Company’s devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This listing allows for transparency and traceability of devices marketed within the EU, though the company itself is not based in the EU. EUDAMED is used to track devices classified under EU regulations, including those that may be imported or distributed there.

All of Becker Orthopedic Appliance Company’s devices fall under Class I regulatory classification. This classification typically applies to low-risk devices like orthopedic components, straps, and footplates, which pose minimal risk to patients when used as intended. Class I devices often require less stringent regulatory oversight compared to higher-risk categories, though they must still meet safety and performance standards.