Electric Wheelchair (F309)

The Electric Wheelchair (F309) is a battery-powered, four-wheeled mobility device designed for disabled or elderly persons with limited mobility. It features a joystick-controlled driving system, automatic electromagnetic brakes, lithium-ion batteries, and can be used both indoors and outdoors on level ground and slopes up to 6 degrees.

The F309 uses brushless DC motors (180W×2 at 24VDC), a WS-24V electronic controller, 8-inch solid rear tires and 7-inch solid front tires, and lithium-ion batteries (24V, 9.09Ah, 218Wh). Minor differences from the predicate include a smaller rear wheel (8-inch vs. 24-inch), slightly lower forward speed (6.48 vs. 6.84 km/h), lower obstacle-climbing height (20mm vs. 25mm), and greater battery range (20km vs. 8.2km).

ISO 7176 series (parts 1–11, 13–15, 21, 25) covering stability, braking, energy consumption, dimensions, strength, climatic performance, seating, EMC, and batteries; ISO 10993-1 for biocompatibility; ISO 16840-10 for ignition resistance; and IEC 60601-1-2:2014+A1:2020 for electromagnetic disturbances.

The subject device performs the same intended function and is intended for the same user population as the predicate K242989. All observed differences (wheel size, speed, obstacle-climbing, mass, dimensions, motor output, controller model) are minor and have been tested against ISO 7176 standards with results meeting design specifications. The device maintains equivalent safety, effectiveness, and performance in static/dynamic stability, braking, battery performance, and biocompatibility, with no deleterious effect on safety or effectiveness from these minor variations.