Mobility Scooter (MS160C)

The Mobility Scooter (MS160C) is a battery-powered, four-wheeled motorized vehicle designed to provide mobility for disabled or elderly persons limited to a seated position. It is intended for both indoor and outdoor use and features a seat, foldable handles, control panel, and electromagnetic braking system powered by two lead-acid batteries.

The subject device is substantially similar to the predicate (W3468) in core design: both are four-wheeled, battery-powered scooters with adjustable seating, foldable frames, and electromagnetic brakes. Minor differences include frame material (aluminum alloy vs. steel), motor power (180W vs. 250W), front wheel size (8 inches vs. 9 inches), and slightly lower cruising range (17.5 km vs. 20 km). Both use 24V lead-acid battery systems and off-board chargers.

Testing performed per ISO 7176 series standards including static/dynamic stability, brake effectiveness, energy consumption, dimensions, speed/acceleration, seating dimensions, strength testing, climatic conditions, obstacle-climbing ability, biocompatibility (ISO 10993-1, -5, -10, -23), electromagnetic compatibility (IEC 60601-1-2:2020), and power/control systems (ISO 7176-14:2008).

Both devices completed full performance testing against the ISO 7176 series standards with equivalent or superior results, demonstrating comparable safety and effectiveness. Material and dimensional differences (aluminum vs. steel frame, 8-inch vs. 9-inch front wheels, 180W vs. 250W motor) do not raise new safety concerns because all performance criteria—stability, braking distance, maximum speed, and load capacity—meet or exceed predicate standards. The control systems, though using different controllers, are functionally similar and both validated per ISO 7176-14:2008. Biocompatibility materials are identical between devices.