Power Wheelchair (D26)

The Power Wheelchair (D26) is a motor-driven, foldable, battery-operated indoor and outdoor transportation device designed to provide mobility to disabled or elderly persons limited to a seated position. It features a rear-wheel drive system, joystick control with Bluetooth remote controller capability, and manual fold/expand functionality.

The subject device is substantially identical to the predicate device (K242448) across all major parameters: same dimensions (1150mm × 600mm), wheel configuration (7-inch front, 12-inch rear PU solid tires), brushless motor (24VDC, 250W × 2), maximum speed (6 km/h), brake system (electromagnetic), and control method (joystick plus Bluetooth). Minor differences include travel range (12.8 km vs. 20 km) and maximum loading weight (180kg vs. 120kg), neither of which raises new safety concerns.

ISO 7176 series standards (parts 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 21, 22, 25), ISO 16840-10:2021, ISO 10993 series for biocompatibility, IEC 60601-1-2:2020 for electromagnetic compatibility, and FDA guidance for power wheelchairs.

The subject device performs identically to the predicate device across all critical safety and performance attributes including static and dynamic stability, brake performance, electromagnetic compatibility, electrical safety, battery operation, and obstacle-climbing ability. Both devices comply with the same ISO standards and control criteria, and testing demonstrates equivalent performance. Minor parameter variations (travel distance and load capacity) do not introduce new safety or effectiveness concerns and are consistent with design optimization rather than fundamental design changes.