Mobility Scooter (X-12, X-14, X-17)

The Mobility Scooter (X-12, X-14, X-17) is a motor-driven indoor and outdoor transportation vehicle designed to provide mobility to disabled or elderly persons who are limited to a seated position. It features two front wheels, two rear wheels, two support wheels, a seat, tiller console, electric motor, electromagnetic brake, rechargeable lithium-ion battery, and an off-board charger.

The subject device has a 24V 180W motor and 24V 10Ah lithium-ion battery, compared to the predicate's 24V 350W motor and 25.6V 15Ah battery. The subject weighs 24kg with maximum speeds of 7.2-7.56 km/h and variable maximum loading (100-120kg by model), versus the predicate's 54kg, 7.92 km/h, and 150kg capacity. Both use electromagnetic brakes, foldable seats, and removable batteries, but differ in frame material (aluminum alloy vs. steel), ground clearance (38mm vs. 20mm), and dimensions.

ISO 7176 series (Parts 1-15, 21-22, 25), ISO 16840-10 (ignition resistance), IEC 60601-1-2 (electromagnetic compatibility), and FDA's 2023 Guidance on Device Software Functions. Testing covered static/dynamic stability, brake effectiveness, range, seating, wheel dimensions, obstacle climbing, and battery/charger performance.

The subject device and predicate comply with identical ISO standards and demonstrate substantially equivalent performance. Minor differences in motor power, battery capacity, weight, and dimensions do not impact safety or effectiveness because both devices meet the same performance acceptance criteria under the ISO 7176 standards. Non-clinical laboratory testing supports that the subject device performs as intended for its specified use conditions.