Hovertech International

Hovertech International specializes in devices that assist with patient mobility and handling. Their primary products include powered patient transfer systems, such as slings and mats (like the HoverSling and SizeWise Matt), which are designed for single-use or reusable applications. They also produce air-powered patient lifting belts/harnesses and medical device air compressors (e.g., HoverTech Air Supply). These devices are engineered for clinical environments to support safe and efficient patient transfers.

Hovertech International is based in the United States. Their devices are registered in two key regulatory databases: EUDAMED (the European database for medical devices) and the FDA’s Unique Device Identifier (UDI) system in the U.S. These listings ensure compliance with regulatory requirements in the European Economic Area and United States, where applicable.

Hovertech International’s devices fall under Class I and Class II classifications. The classification determines regulatory oversight and requirements for market authorization. For example, powered patient transfer systems (like slings or mats) are often Class II due to their role in patient safety and risk mitigation, while simpler air compressors or manual belts may qualify as Class I. Classification depends on factors like intended use, risk, and design complexity as defined by regional regulations.

Yes, Hovertech International’s devices are designed for global markets, including the European Economic Area (EEA) and the United States. This means their products must comply with EU MDR (Medical Device Regulation) requirements for EEA markets and FDA regulations for U.S. sales. Each region has its own classification system (e.g., EU’s Class I/II vs. FDA’s Class I/II/III), so devices may undergo separate evaluations or registrations depending on the destination. Their listings in EUDAMED and FDA UDI reflect this global approach.