Electric Wheelchair (YE200)

The Electric Wheelchair (YE200) is a motor-driven, foldable powered wheelchair designed for indoor and outdoor use to provide mobility to disabled or elderly persons limited to a seated position. It features rechargeable lithium-ion batteries, joystick control, and electromagnetic braking, with a maximum load capacity of 120 kg.

The YE200 uses an aluminum alloy frame (versus the predicate's carbon fiber), has slightly different wheel sizes (182mm×55mm front, 350mm×61mm rear), lower maximum speed (5.7 km/h vs 6 km/h), reduced ground clearance (100mm vs 160mm), and different seat cushion materials (polyester mesh with sponge vs linen with PU foam). Both devices share the same brushless DC motor design, dual drive controller, joystick control method, and electromagnetic brake system.

ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10:2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, IEC 60601-1-2:2020.

Both devices share identical intended use, classification, regulatory requirements, and core design principles including joystick control, brushless DC motor system, and electromagnetic braking. Although the YE200 uses aluminum instead of carbon fiber frame material and has minor dimensional and performance differences (speed, ground clearance, wheel size), all safety and performance testing on the subject device passed and these differences do not raise new safety concerns. Biocompatibility testing confirmed equivalence, and both devices comply with the same ISO wheelchair standards, demonstrating that functional and safety characteristics are substantially equivalent despite material and dimensional variations.