eFOLDi Navigator Powerchair (STPC-A)

The eFOLDi Navigator Powerchair (STPC-A) is a motor-driven, electrically powered wheelchair designed for indoor and outdoor use. It provides mobility to disabled or elderly persons limited to a seated position, featuring rear-wheel drive, joystick and attendant controls, and a foldable design for portability.

The device uses a magnesium alloy frame, two 24V 180W brushless DC motors, rechargeable lithium-ion battery (24VDC, 10Ah, 240Wh), maximum speed of 5.6 km/h, weight capacity of 120 kg, and electromagnetic braking system. It includes anti-tipper device, solid polyurethane wheels, and operates safely on slopes up to 6 degrees with a braking distance of ≤1.5 meters.

ISO 7176 series (parts 1–11, 14) for wheelchair stability, dynamics, braking effectiveness, energy consumption, dimensions, speed, seating, and structural strength; ISO 16840-10:2021 for ignition resistance of seating materials; IEC 62133-2 for lithium battery safety; ISO 10993-1 for biocompatibility of user-contacting materials.

The subject device shares identical intended use, four-wheel configuration, rear-wheel drive, automatic electromagnetic braking, maximum incline (6°), and operating environment (indoor/outdoor) with the predicate device K232121. Minor differences in materials (magnesium vs. aluminum frame, PVC vs. PU armrest) and battery specifications (10Ah vs. 6Ah) do not affect safety or effectiveness. Nonclinical testing demonstrates compliance with applicable ISO standards, confirming the device performs as safely and effectively as the predicate.