FLIGHT MEDICAL INNOVATIONS LTD

Flight Medical Innovations Ltd specializes in ventilator-related products, including single-use ventilator breathing circuits, anaesthesia ventilators, and transport electric ventilators. Their portfolio also includes accessories like gas cylinder holders, instrument transport racks, lung physical simulators, and custom medical device mounts. These devices are designed to support respiratory care, equipment transport, and storage in clinical settings.

Flight Medical Innovations Ltd is based in the United States. Since their devices are regulated under FDA guidelines, they appear in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. This means their products are tracked and listed under U.S. regulatory frameworks, ensuring compliance with FDA requirements for Class II devices.

Flight Medical Innovations Ltd’s devices are listed in the FDA’s 510(k) and UDI databases. The 510(k) registry documents premarket submissions for Class II devices to demonstrate substantial equivalence to existing approved products, while the UDI system ensures traceability and identification of medical devices throughout their lifecycle. Both registries are critical for tracking compliance and safety in the U.S. market.

Flight Medical Innovations Ltd’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The company’s ventilators, accessories, and transport solutions fall under this category due to their role in critical patient care and equipment management.