Electric Wheelchair (LW01301A07)

The Electric Wheelchair (LW01301A07) is a motor-driven, indoor and outdoor transportation vehicle designed to provide mobility to disabled or elderly persons limited to a seated position. It features a joystick-controlled system with four wheels, an automatic electromagnetic brake, and a rechargeable Li-ion battery with 17.6 km range.

The device uses direct drive on rear wheels, automatic electromagnetic braking, and joystick control similar to the predicate. Key differences include aluminum alloy frame (vs. carbon fiber), different wheel sizes and types (12″×2″ pneumatic rear vs. 8.5″×2″ solid), higher maximum speed (6.84 km/h vs. 6 km/h), lower maximum loading weight (120 kg vs. 136 kg), and slightly different dimensions and braking distance (1.2 m vs. 1.5 m).

ISO 7176 series (Parts 1-15, 21-22, 25) covering static/dynamic stability, brake effectiveness, energy consumption, dimensions, speed, seating, strength, climatic testing, obstacle-climbing, electromagnetic compatibility, and batteries. Also ISO 10993 series for biocompatibility and IEC 60601-1-2:2014 for electromagnetic compatibility.

All dimensional and performance differences (frame material, wheel sizes, speeds, braking distance, loading weight) do not create new safety or effectiveness concerns because the subject device meets the same ISO 7176 and ISO 10993 consensus standards as the predicate, with equivalent test results demonstrating comparable static/dynamic stability, brake performance, obstacle-climbing ability, and biocompatibility. The minor variations in design parameters are within acceptable ranges and do not alter the fundamental intended use or safety profile.