ANODYNE THERAPY, L.L.C.

Anodyne Therapy, LLC specializes in non-wearable musculoskeletal infrared phototherapy units. These devices are designed to deliver controlled infrared light for therapeutic purposes, such as pain relief and tissue healing in clinical settings like physical therapy or medical offices. The focus is on musculoskeletal applications, meaning they target muscles, bones, and connective tissues.

Anodyne Therapy, LLC is based in the United States. Its devices are specifically intended for commercial distribution within the U.S., where they undergo regulatory oversight under U.S. laws. The company does not provide information on international distribution or markets outside the U.S.

Anodyne Therapy’s devices are classified as Class II under U.S. regulatory standards. Class II classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness—such as infrared phototherapy units, where controlled light delivery is critical but does not carry the highest risk level (e.g., life-supporting or implantable devices). This classification requires compliance with specific regulatory requirements, including performance testing and labeling standards.

Yes, Anodyne Therapy’s devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system assigns a unique identifier to medical devices to improve tracking, transparency, and post-market surveillance. Listing in this database helps healthcare providers, regulators, and manufacturers verify device details like specifications, manufacturer information, and regulatory status.