AXIOSONIC, LLC

Axiosonic, LLC specializes in physical therapy ultrasound systems, which are primarily used for musculoskeletal rehabilitation and tissue healing. These devices, such as the JAS Pulse (3MHz and standard) and the AxioSonic Physiotherapy system, deliver focused ultrasound therapy for clinical and patient home-use settings. The technology is designed to promote healing and reduce pain in soft tissues.

Axiosonic, LLC is based in the United States, meaning its devices fall under FDA jurisdiction. Since the company’s products are classified as Class II devices, they are subject to FDA’s performance-based regulations, which require compliance with specific design controls, labeling requirements, and post-market surveillance—though individual devices must still undergo their own authorization process.

Yes, Axiosonic, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and patients to verify product details like model, manufacturer, and batch information. Listing in the UDI system is a requirement for Class II devices to facilitate recalls, compliance checks, and post-market monitoring.

Axiosonic, LLC’s physical therapy ultrasound systems are classified as Class II devices by the FDA. This classification indicates that while they pose a moderate risk, they are not considered high-risk (Class III). As a result, these devices require compliance with special controls—such as performance standards, labeling requirements, and risk management—but do not undergo the same rigorous pre-market approval process as Class III devices. The classification reflects their intended use for therapeutic applications with established safety and effectiveness.