Power Mobility Scooter (MJMA01, MJMA02)

The Power Mobility Scooter (MJMA01, MJMA02) is a motor-driven, battery-powered four-wheeled vehicle designed for indoor and outdoor transportation to provide mobility to disabled or elderly persons limited to a seated position. The device has a maximum loading capacity of 120 kg and includes features such as electromagnetic brakes, a lithium-ion battery with off-board charger, seat with back support, and anti-tip devices. MJMA01 lacks armrests while MJMA02 is equipped with armrests—the only difference between the two models.

The subject device uses an aluminum alloy frame versus the predicate's steel frame, weighs 29–31 kg versus 42 kg, and has a slightly higher motor output (24 V 250W versus 24 V 180W). It uses a lithium-ion battery (24V 5.8Ah×2) instead of lead-acid (12V 12Ah×2), achieves 6.84 km/h max speed versus 6 km/h, can climb a 10° slope versus 9°, and has a 16.3 km travel range versus 15 km. Overall dimensions, wheel diameters, ground clearance, turn radius, and brake characteristics are all similar.

ISO 10993-5, 10993-10, 10993-23 (biocompatibility); ISO 7176-1 through 7176-25 (wheelchairs and powered scooters—stability, braking, energy, dimensions, strength, climatic, obstacles, EMC, batteries); ISO 16840-10 (ignition resistance); IEC 60601-1-2:2014+A1:2020 (electromagnetic disturbances).

The proposed device is substantially equivalent because it has the same intended use, drive system, braking mechanism, and operating environment as the predicate device. Although there are minor differences in frame material, weight, battery type, and performance parameters (speed, slope, range), all differences have been tested according to ISO 7176 series standards and meet design specifications. The test data support that these differences do not deleteriously affect safety or effectiveness, and the device performs the same function as the predicate.