Power Wheelchair (MOB1107)

The Power Wheelchair (MOB1107) is a battery-powered, four-wheeled vehicle intended to provide mobility to disabled or elderly persons limited to a seated position for both indoor and outdoor use. It is controlled via a joystick, powered by a lithium-ion battery and DC motor, and features automatic electronic braking.

The subject device uses a 25.2V 6Ah lithium-ion battery with 180W DC motor, achieving 6.5 km/h max forward speed and 7.5 km maximum range on a full charge. It has a 4-wheel design with 7-inch front and 12-inch rear PU solid tires, aluminum alloy frame, automatic electronic brake system with ≤0.9 m braking distance, and joystick control. Minor dimensional differences exist compared to the predicate (1000×620×900 mm vs. 1010×620×900 mm overall), but these do not affect safety or effectiveness.

ISO 7176 series standards (parts 1–15, 21–22, 25), ISO 16840-10 (resistance to ignition), IEC 60601-1-2 (electromagnetic compatibility), and the 1995 FDA Guidance on 510(k) Submissions for Mechanical and Powered Wheelchairs. The subject device also includes enhanced-level software documentation per FDA's 2023 Guidance on Device Software Functions.

The subject device and predicate (K242791) comply with identical ISO 7176 standards and demonstrate equivalent performance across all critical parameters: static and dynamic stability, brake effectiveness, theoretical range, dimensions, maximum speed, wheel specifications, obstacle-climbing ability, and electromagnetic compatibility. Both devices employ the same control architecture (joystick-based), motor specifications (180W DC), braking mechanism (automatic electronic), and material composition (aluminum alloy frame, polyester cushioning). Non-clinical laboratory testing confirms the subject device meets all acceptance criteria and performs as intended in specified use conditions, establishing substantial equivalence.