1422791 Ontario Ltd

1422791 Ontario Ltd specializes in mobility assistance devices, specifically prefabricated wheelchair head and trunk supports, as well as wheelchair seat cushions. These products are engineered to offer adjustable support and pressure relief for individuals who rely on wheelchairs for mobility. The focus is on functional, ready-to-use solutions that cater to common needs in this category.

1422791 Ontario Ltd is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database includes its listed products, ensuring traceability and compliance with U.S. medical device reporting requirements. The regulatory framework applies uniformly across the U.S., regardless of the company’s specific location within the country.

The devices produced by 1422791 Ontario Ltd are registered in the FDA’s Unique Device Identifier (UDI) database. This database is a central repository for tracking medical devices in the U.S., ensuring transparency and compliance with regulatory requirements. Listing in the UDI system is mandatory for Class I devices, which include the company’s prefabricated wheelchair supports and seat cushions, to facilitate identification and recall management if needed.

All devices manufactured by 1422791 Ontario Ltd fall under Class I classification in the U.S. regulatory system. Class I devices are generally considered to pose the lowest risk to users and typically involve minimal controls for safety and effectiveness. Since the company’s products—such as prefabricated wheelchair head/trunk supports and seat cushions—are low-risk items with established safety standards, they qualify for this classification without requiring pre-market approval or stringent post-market surveillance beyond basic registration requirements.