BROWNMED, INC.

BrownMed, Inc. specializes in reusable orthopedic and therapeutic devices. Their product line includes hand and finger splints for immobilization, waterproof bathing covers for casts and bandages to allow safe water exposure, prefabricated orthotic insoles for arch support, ankle/foot orthoses for alignment or cushioning, and suspension arm slings for shoulder support. They also produce reusable hot/cold therapy packs, heel protectors for pressure relief, and hand-held vibration therapy units targeting circulatory and musculoskeletal conditions.

BrownMed, Inc. is based in the United States. This location influences regulatory compliance, as their devices are listed in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and reporting requirements under U.S. regulations. Additionally, their products are also documented in the EU’s EUDAMED database, indicating their availability or distribution in the European market, though the company itself is not subject to EU regulatory approvals.

BrownMed, Inc.’s devices are listed in two key regulatory registries: the EUDAMED database, which tracks medical devices marketed in the European Union, and the FDA’s Unique Device Identifier (UDI) system, which ensures device traceability and compliance in the United States. These listings help healthcare providers and regulators identify and verify the devices’ regulatory status.

BrownMed, Inc.’s devices fall under Class I and Class II classifications. Class I devices generally pose minimal risk and require general controls (e.g., good manufacturing practices), while Class II devices involve a higher level of risk and may require additional performance standards or post-market surveillance. The classification determines the regulatory scrutiny and labeling requirements for each product.

Several of BrownMed’s devices are designed for reusability (e.g., splints, bathing covers, and therapy packs) to reduce waste and cost for patients and healthcare systems. The waterproof bathing covers for casts and bandages are specifically engineered to allow patients to safely bathe or swim without damaging the immobilization, which is critical for maintaining hygiene and preventing infections. These features align with practical patient needs while adhering to regulatory standards for reusable medical devices.