Mobility Scooter (BC-MS310)

The Mobility Scooter (BC-MS310) is a motor-driven, indoor and outdoor transportation vehicle designed to provide mobility for disabled or elderly persons who are limited to a seated position. It features an aluminum alloy frame, electric motor powered by a rechargeable lithium-ion battery, dual front and rear wheels, a tiller console with throttle controls, and an automatic electromagnetic brake. The device has a maximum load capacity of 100 kg and can be manually folded for portability.

The proposed device differs from the predicate in frame material, size, load capacity, weight, ground clearance, turn radius, drive system, battery type, charger design, controller, motor output, maximum speed, travel distance, and total mass. Despite these minor differences, the design and technological characteristics remain fundamentally similar to the predicate device.

ISO 7176 series (parts 1–25) for wheelchair performance including static/dynamic stability, brake effectiveness, energy consumption, dimensions, speed, strength, climatic conditions, and electromagnetic compatibility; IEC 60601-1-2 and IEC TR 60601-4-2 for electromagnetic compatibility; IEC 62133-2:2017+A1:2021 for lithium battery safety; ISO 14971:2019 for risk analysis; ISO 16840-10:2021 for seating ignition resistance.

The proposed scooter is substantially equivalent to the predicate device (K250533) because the design and technological characteristics are fundamentally similar, and all parameters with differences have been tested according to ISO 7176 series standards. These test records support the device's safety and effectiveness, and the minor differences do not adversely affect safety or intended use, demonstrating substantial equivalence.