Electrically Powered Wheelchair (Model YC-01)

The Electrically Powered Wheelchair (Model YC-01) is a motor-driven indoor and outdoor transportation vehicle designed to provide mobility to disabled or elderly persons limited to a seated position. It is powered by a lithium-ion battery pack, controlled via a joystick, and includes an automatic electromagnetic brake system.

The proposed device uses a carbon fiber frame (versus aluminum alloy in the predicate), has an 8-inch front wheel (versus 7-inch), a slightly more powerful brushless DC motor (200W versus 150W), a narrower turning radius (590mm versus 900mm), and a higher maximum loading capacity (136kg versus 120kg). Battery capacity is marginally higher (25.55V 10.4Ah×2 versus 25.2V 10.4Ah×2). All other core features—joystick control, electromagnetic braking, dual-drive system, maximum speed, and dimensions—remain substantially similar.

ISO 7176 series (Parts 1-15, 21-22, 25, 31), ISO 16840-10:2021 (flame resistance), IEC 60601-1-2, IEC TR 60601-4-2, IEC 62133-2:2017+A1:2021 (battery safety), ANSI C63.18:2014 (EMC), and FDA's 2023 Biocompatibility Guidance.

Both devices have identical intended use, the same design principles for controller and braking systems, and comply with the same ISO 7176 standards. Minor differences in frame material, wheel size, motor power, and loading capacity do not raise new safety or effectiveness concerns because all safety and performance testing demonstrates compliance with ISO 7176 requirements. Biocompatibility is established through low-risk materials per FDA guidance. The devices are functionally equivalent in operation and safety performance.