Mobility Scooter (Model X-01, X-02)

The Mobility Scooter (Models X-01, X-02) is a battery-powered, indoor/outdoor electric transportation device designed for disabled or elderly persons with limited mobility who are able to remain seated. It features a rear-wheel drive system with electromagnetic braking, a maximum weight capacity of 120 kg (265 lbs), and a maximum speed of 7 km/h with a theoretical range of 15 km per charge.

The subject device uses a brushless DC motor (24V, 250W) with lead-acid batteries (12V, 12Ah, 2 pcs), while the predicate uses a brush differential rear axle (24V, 180W) with lithium-ion batteries (24V, 6AH, 2 pcs). Both have electromagnetic braking, foldable frames, and similar control interfaces using a tiller handle with thumb-operated throttle. Minor differences include front wheel size (8 inch vs 7 inch), overall weight (44 kg vs 29 kg), and performance parameters such as max speed (1.94 m/s vs 1.67 m/s) and turning radius (1400 mm vs 1200 mm).

ISO 7176 series (Parts 1-15, 21-22, 25) for wheelchair stability, braking effectiveness, energy consumption, dimensions, speed, obstacle climbing, seating, structural strength, climatic testing, electromagnetic compatibility, and battery/charger requirements. Additional standards include IEC 60601-1-2:2014 for electromagnetic compatibility and EN 12184:2014 for electrically powered wheelchairs. Biocompatibility testing per ISO 10993-1, 10993-5, 10993-10, and 10993-23.

Both devices are Class II motorized three-wheeled scooters with identical intended use, same product code (INI), regulatory class, and patient population. Despite minor differences in motor type, battery chemistry, and performance parameters, both completed identical ISO 7176 series performance testing with no safety or effectiveness concerns identified. The differences in motor power, battery capacity, speed, and dimensions are insignificant and do not introduce new safety or effectiveness issues; both devices employ equivalent control systems, electromagnetic braking, and user interfaces with the same operational principles.