Mobility Scooter (JT10)

The Mobility Scooter (JT10) is a motorized three-wheeled vehicle designed to provide mobility to disabled or elderly persons limited to a seated position. It features a steel frame, two front and rear wheels, anti-tip wheels, an electric motor, electromagnetic brake, and rechargeable lead-acid batteries. The device is controlled via a tiller console with throttle lever, speed knob, and handle, and is intended for both indoor and outdoor use on flat surfaces.

The JT10 differs from the predicate device (W3431D) in several design parameters: larger overall dimensions (1080×505×870 mm vs 90×59×99 cm), increased motor output (300W vs 180W), higher battery capacity (12V 20Ah vs 12V 12Ah), greater max load capacity (136 kg vs 120 kg), longer travel distance (25 km vs 15 km), and slightly lower max speed (5.79 km/h vs 6 km/h). Both devices use the same controller (PG45A), electromagnetic brakes, rear-wheel drive, and similar frame design with foldable seats and removable battery packs.

The device was evaluated using ISO 7176 series standards covering stability (ISO 7176-1, 7176-2), brake effectiveness (ISO 7176-3), energy consumption (ISO 7176-4), dimensions and mass (ISO 7176-5), maximum speed (ISO 7176-6), seating dimensions (ISO 7176-7), structural strength (ISO 7176-8), climatic testing (ISO 7176-9), obstacle-climbing ability (ISO 7176-10), and power systems (ISO 7176-14). EMC testing followed ISO 7176-21 and IEC 60601-1-2:2014. Biocompatibility was assessed per ISO 10993-5, 10993-10, and 10993-23.

The JT10 is substantially equivalent because it shares the same intended use, product code (INI), regulatory classification (Class II), and fundamental design approach as the predicate device. Although the subject device has higher motor power, battery capacity, and load capacity, these differences do not introduce new safety concerns because the device has passed all applicable ISO 7176 performance and safety standards identical to those met by the predicate. The enhanced specifications (larger motor, greater load) actually provide equal or improved performance margins without raising novel risks; the reduced slope grade ability (6° vs 9°) is a less capable feature posing no safety issue. All differences in dimensions, weight, and performance metrics were evaluated and determined not to create new safety or effectiveness concerns.