Electric Wheelchair (MP148)

The Electric Wheelchair (MP148) is a battery-powered, four-wheeled motor-driven device intended for indoor and outdoor transportation of disabled or elderly persons limited to a seated position. It features joystick control, automatic electromagnetic braking, and is designed for a maximum occupant weight of 120 kg.

The subject device uses a magnesium alloy frame and polyurethane armrest, compared to the predicate's carbon fiber materials. It has a slightly smaller overall width (590 mm vs 640 mm) and different wheel dimensions (165×37 mm front, 253×43 mm rear vs 175×48 mm and 280×48 mm). The subject device achieves a longer maximum travel distance (25.7 km vs 13.3 km) due to dual Li-ion battery packs (25.2 VDC, 10 Ah) versus the predicate's single 24V 10Ah battery.

ISO 7176 series (Parts 1-15, 21-25) covering wheelchair stability, dynamics, braking, energy consumption, dimensions, speed, seating, structural strength, climatic testing, and electromagnetic compatibility. Additional standards include ISO 16840-10:2021 for resistance to ignition, IEC 60601-1-2 and IEC 60601-4-2 for electromagnetic compatibility, ISO 13485 for quality management, and ISO 10993 for biocompatibility of patient-contacting materials.

Both devices are Class II powered wheelchairs with identical intended use, indications, control methods (joystick), and driving systems (direct rear-wheel drive). Material differences (magnesium alloy frame vs carbon fiber, polyurethane vs carbon fiber armrest) and minor dimensional variations do not impact safety or effectiveness because performance testing per ISO 7176 series demonstrates equivalent functionality in static/dynamic stability, braking, speed, and structural integrity. The predicate device (K243440) was cleared under the same regulatory pathway and standards.