Electrically Powered Wheelchair

The HP206 is an electrically powered wheelchair designed for indoor and outdoor use to provide mobility to disabled or elderly persons limited to a seated position. It features a foldable aluminum alloy frame, lithium battery power source, joystick control, and a maximum loading capacity of 120 kg for one person.

The proposed device differs from the predicate (HP358EA) primarily in two components: the motor type (DC Brushless 24Vdc 170W versus DC Brush 24Vdc 250W) and the controller model (M7084 versus PG D51492). Both devices share identical indications for use, design principles, frame material, brake system, battery specifications, and safety features. Minor differences in dimensions, speed, braking distance, turning radius, and obstacle-climbing ability (35mm versus 30mm) are noted but not clinically significant.

ISO 7176 series (parts 1-15, 21-22, 25), ISO 16840-10, ISO 10993-5/10/23 (biocompatibility), IEC 60601-1-2 (electromagnetic compatibility), and ISO 14971 (risk analysis). Performance validated against static stability, dynamic stability, brake effectiveness, obstacle climbing, speed, energy consumption, and seating dimensions.

The devices are substantially equivalent because they share identical intended use, structure, composition, and operating principles. Both comply with the same ISO standards for powered wheelchairs and meet equivalent safety requirements including biocompatibility and electromagnetic compatibility. The controller and motor design principles are functionally equivalent despite different models, with software validation performed on both. Minor performance variations do not raise new safety or effectiveness concerns and all differences comply with applicable ISO 7176 and IEC standards.