Electric wheelchair

The Electric Wheelchair (models DH01120, DH01105(4)) is a motor-driven vehicle designed for indoor and outdoor mobility assistance for disabled or elderly persons limited to a seated position. It features a lithium battery power system, joystick control, electromagnetic braking, and is composed of a frame, motor, controller, battery, and seat cushion.

The device has the same intended use, mode of action, and operational characteristics as the predicate device (K232193). Minor differences include slightly lower braking distance (≤1.0m vs ≤1.5m), lower max forward speed (4.5 km/h vs up to 6 km/h), lower maximum loading weight (100 kg vs 120 kg), and lower obstacle climbing ability (25mm vs 40mm). All other features—4-wheel configuration, joystick control, direct rear-wheel drive, electromagnetic braking, and 20 km range—are equivalent.

Performance tested per ISO 7176 series (Parts 1-15, 21-22, 31), covering stability, braking effectiveness, energy consumption, speed, seating, structural strength, climatic performance, and lithium-ion battery systems. EMC/electrical safety tested per ISO 7176-21, IEC 60601-1-2:2014/AMD1:2020, ANSI C63.18-2014, and IEC 61000-4-39:2017. Biocompatibility assessed per FDA's 2023 Biocompatibility Guidance.

The Electric Wheelchair is substantially equivalent to predicate device K232193 because it shares identical intended use, design principles, materials, and operational characteristics. Minor performance differences (lower speed, loading capacity, and obstacle climbing) do not raise new safety or effectiveness concerns and remain compliant with applicable ISO standards. Clinical testing was deemed unnecessary to demonstrate substantial equivalence.