LEGGERO LLC

Leggero LLC specializes in attendant-only-propelled wheelchairs that are not designed for bariatric (heavyweight) use. Their product line includes lightweight and maneuverable models like the Enzo, Dyno, Reach, and Track, as well as the Element Pediatric Wheelchair, which is specifically designed for children. These devices are intended for use by caregivers to assist individuals who require mobility support.

Leggero LLC is based in the United States. Their devices are authorized for use in both the US and the European Union, as evidenced by their inclusion in the FDA’s 510(k) and UDI registries, as well as the EU’s EUDAMED database. This reflects their compliance with regulatory requirements in these regions.

Leggero LLC’s devices are listed in three key regulatory databases: the EU’s EUDAMED system, the FDA’s 510(k) premarket notification registry (for US clearance), and the FDA’s Unique Device Identification (UDI) system. These listings demonstrate their devices’ compliance and traceability in both the US and EU markets.

All of Leggero LLC’s devices fall under Class I regulatory classification in both the US and EU. Class I devices are generally considered low-risk and often subject to fewer regulatory controls, such as general controls (e.g., good manufacturing practices) rather than specific device requirements. This classification aligns with their attendant-propelled wheelchairs, which are non-invasive and pose minimal risk.

The FDA’s Unique Device Identification (UDI) system requires manufacturers to assign a unique identifier to medical devices to improve tracking, reduce medical errors, and enhance post-market surveillance. Leggero LLC’s devices are included in this system because they are commercialized in the US, where UDI compliance is mandatory for certain device types—including wheelchairs—to ensure transparency and traceability throughout the supply chain.