Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)

This electric wheelchair is a battery-powered, four-wheeled transportation device designed to provide mobility to disabled or elderly persons with mobility limitations who are seated. It features a lithium battery, brushless DC motors, joystick control, electromagnetic brakes, and can fold for storage. The device is intended for both indoor and outdoor use with a maximum occupant weight of 100 kg.

The subject device uses brushless DC motors (24VDC, 250W, 2 units), automatic electromagnetic braking, joystick control, and lithium-ion batteries. Key differences from the predicate include frame materials (aluminum alloy with ABS coating or carbon fiber with PUR coating versus magnesium alloy), total mass ranging from 16-27 kg versus 19 kg, variable wheel sizes, max speeds of 5.76-6.84 km/h forward versus 6.1 km/h, and loading capacity of 100 kg versus 120 kg. The subject device also uses an SYC-PM30 controller versus a DZWN2435-BWL controller in the predicate.

ISO 7176 series (Parts 1-11, 13-15, 21, 25), ISO 10993-1:2018 (biological evaluation), ISO 16840-10:2021 (flame resistance), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), and IEC 62133-2:2017 (lithium battery safety).

Both devices share identical indications for use, the same folding frame design principles, equivalent control and driving systems meeting ISO 7176-14, identical brake system design per ISO 7176-3, and both use lithium-ion batteries with off-board chargers. Minor differences in materials, weight, wheel dimensions, speeds, and loading capacity do not raise new safety or effectiveness concerns because all devices meet the same ISO 7176 performance standards, and differences such as shorter braking distances actually enhance safety. Both undergo identical flame-retardant testing per ISO 16840-10.