ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)

The QDWP-A01 and QDWP-B02 are motor-driven, indoor and outdoor electric wheelchairs designed to provide mobility to disabled or elderly persons limited to a seated position. The QDWP-A01 uses lithium batteries while the QDWP-B02 uses lead-acid batteries. Both feature a foldable frame, joystick control, automatic electromagnetic braking, and a maximum load capacity of 120 kg for one person.

The subject device and predicate device (K113463) share identical indications for use, design principles, structure, composition, and operating principles. Both use joystick-controlled direct drive on rear wheels with automatic electromagnetic brakes. Minor differences exist in frame material (aluminum for QDWP-A01 versus steel for QDWP-B02), motor type (brushless versus brushed), controller specifications (24V 40A versus 24V 35A), and slight variations in braking distance, turning radius, and obstacle-climbing ability—all within acceptable ranges that do not impact safety or effectiveness.

ISO 7176 series (Parts 1–15, 21–22, 25); ISO 10993-5, 10993-10, and 10993-23 (biocompatibility); ISO 16840-10 (flame-retardant seating); ISO 14971 (risk analysis); IEC 60601-1-2 (electromagnetic compatibility); FDA guidance for power wheelchair submissions.

The subject device meets all relevant ISO wheelchair standards identical to the predicate device. While the QDWP-A01 differs in motor type and the QDWP-B02 differs in frame material and battery type, these differences are demonstrated through comprehensive performance testing to not introduce new safety or effectiveness concerns. Biocompatibility testing confirms materials are safe; electromagnetic compatibility and performance testing show both devices meet the same ISO requirements. All dimensional and performance variations (braking distance, speed, turning radius) fall within acceptable ranges that do not alter the fundamental safety profile, thus establishing substantial equivalence.