Magnesium alloy scooter (RS100)

The Magnesium alloy scooter (RS100) is a battery-powered, three-wheeled motorized mobility device designed to provide indoor and outdoor transportation for disabled or elderly persons who are unable to walk. It features a lithium-ion battery, electromagnetic brakes, and a lightweight magnesium alloy frame with a maximum load capacity of 125 kg.

The RS100 uses a front-wheel drive system with a 24V 150W motor, compared to the predicate's rear-wheel drive with 24V 180W motor. It features a lighter magnesium alloy frame (19 kg total mass) versus the predicate's steel frame (40 kg), a lithium-ion battery instead of lead-acid, and improved performance specs including 7.56 km/h max speed, 25.3 km travel range, and a 10° max slope capability. Both devices share the same electromagnetic braking system and similar dimensions.

ISO 7176 series standards (Parts 1–9, 10–11, 13–15, 21, 25) covering stability, brake effectiveness, energy consumption, dimensions, speed, seating, structural strength, climatic performance, electromagnetic compatibility, and batteries. Also ISO 10993-1 for biocompatibility, ISO 16840-10 for ignition resistance, and IEC 60601-1-2 for electromagnetic disturbances.

Although the RS100 differs from the predicate in frame material, drive system, battery type, motor power, and performance parameters, all differences are minor and do not affect the device's intended use or safety. Comprehensive non-clinical testing to ISO 7176 series standards demonstrates that the subject device performs equivalently to the predicate across all critical safety and functional characteristics, including stability, braking, dimensional requirements, and electromagnetic compatibility.