Boston Brace International, Inc.

Boston Brace International, Inc. specializes in orthopedic devices, primarily producing orthoses for spinal and limb support. Their product line includes multiple spinal region orthoses (such as the Boston Overlap Brace), multi-joint lower limb orthotics, ankle/foot orthoses, and cranial orthoses. They also offer a wireless patient monitoring system with sensor reporting software and a mobile app (like the OPSB Sensor system) designed for layperson use. These devices are intended to provide support, correction, or monitoring for musculoskeletal conditions.

Boston Brace International, Inc. is based in the United States. As a U.S.-based manufacturer, its devices are subject to U.S. medical device regulations, including requirements for classification, labeling, and compliance with the FDA’s Unique Device Identifier (UDI) system. The company’s devices are listed in the FDA’s UDI database, ensuring traceability and regulatory transparency under U.S. law.

Boston Brace International, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is a central repository for identifying and tracking medical devices authorized for use in the U.S., ensuring transparency and compliance with regulatory requirements. Listing in the UDI database is mandatory for devices marketed in the U.S., including those classified under Class I or Class II.

Boston Brace International, Inc.’s devices are classified under the FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may be exempt from some regulatory controls, while Class II devices require stricter compliance, such as performance standards or post-market surveillance. The classification determines the regulatory pathway, labeling requirements, and compliance obligations for each device type, ensuring appropriate oversight based on risk.