Electric Wheelchair (HG-630)

The Electric Wheelchair (HG-630) is a battery-powered four-wheeled vehicle for indoor and outdoor use. It provides mobility to disabled or elderly persons limited to a seated position, controlled via a joystick and featuring automatic electronic braking.

The subject device uses a 12V lead-acid battery (compared to the predicate's lithium-ion), has a maximum speed of 5.76 km/h with a 13.3 km range, features 8-inch solid front tires and 12-inch solid rear tires, and achieves a 10-degree maximum safe operational incline. Key differences include PU armrests instead of ABS, a braking distance of ≤0.8m versus the predicate's ≤1.5m, and slightly higher maximum obstacle climbing capability at 25mm versus 20mm.

ISO 7176 series (parts 1–15 for stability, dynamics, braking, distance range, dimensions, seating, fatigue, flammability, electrical safety), ISO 16840-10 (resistance to ignition), ISO 10993-5/10/23 (biocompatibility), ISO 7176-21 and IEC 60601-1-2 (electromagnetic compatibility).

Both devices comply with the same comprehensive ISO 7176 and related standards for powered wheelchairs. Performance testing shows the subject device performs substantially similarly to the predicate across all critical parameters: static and dynamic stability, brake effectiveness, theoretical distance range, dimensions, weight, maximum speed, wheel specifications, climatic resistance, and electrical safety. Minor parameter differences (battery chemistry, tire type, armrest material, braking distance) do not raise safety or effectiveness concerns because they fall within the design envelope validated by the same ISO standards both devices meet. The substantially equivalent material composition, mechanical function, intended use, and regulatory compliance basis support the determination.