Electric Wheelchair (GY-E001)

The Electric Wheelchair (GY-E001) is a battery-powered, four-wheeled vehicle designed to provide indoor and outdoor mobility for disabled or elderly persons who are unable to walk. It is controlled via a joystick and includes features such as automatic braking, speed control, and a foldable design for convenient storage and transport.

The device uses a 24V 12Ah lithium-ion battery with a DC motor (24VDC, 250W, 160 r/min), achieving a maximum speed of 6.48 km/h and range of 12.4 km on a full charge. It has 8-inch front wheels and 12.5-inch rear wheels (solid tires), an aluminum alloy frame, PUR armrests, and nylon seat and back cushions. Minor differences from the predicate include braking distance (≤1.0 m vs ≤1.5 m), maximum safe incline (10° vs 6°), and maximum obstacle climbing height (45 mm vs 20 mm).

ISO 7176 series standards (parts 1–21 covering static stability, dynamic stability, braking, energy consumption, dimensions, seating, durability, obstacle climbing, dummies, friction, power systems, labeling, and resistance to ignition), IEC 60601-1-2 (EMC), ISO 10993-5/10/23 (biocompatibility), and ISO 16840-10 (resistance to ignition).

The subject device and predicate device (K240913) share the same intended use, identical indications (motor-driven indoor/outdoor wheelchair for mobility), and perform substantially similar functions using the same control method (joystick) and driving system (direct drive on rear wheels). Both comply with all the same ISO 7176 test standards and pass equivalent performance criteria for stability, braking, range, durability, and safety. Minor parameter differences (battery capacity, speed, wheel size, obstacle climbing height) have all been tested under ISO 7176 standards with results meeting design specifications, demonstrating no deleterious effect on safety or effectiveness. The use of equivalent materials with documented biocompatibility testing supports substantial equivalence in performance and safety.