Electrically Powered Wheelchair

The HP558 is an electrically powered wheelchair designed to provide mobility to disabled or elderly persons limited to a seated position. It features a foldable magnesium alloy frame, lithium-ion battery power, joystick control, and can be used both indoors and outdoors with a maximum user weight of 120 kg.

The proposed device differs from the predicate (HP458E) in three areas: motor (DC brushless 24Vdc 170W versus DC brush 24Vdc 120W), controller (M7084 versus PG Drives VR2), and frame material (magnesium alloy versus aluminum alloy). All other structural components, operational principles, and safety features remain substantially identical.

ISO 7176 series (parts 1-15, 21-22, 25) for wheelchair performance and safety; ISO 10993-5, 10, 23 for biocompatibility; ISO 16840-10 for flame retardancy; IEC 60601-1-2 for electromagnetic compatibility; ISO 14971 for risk analysis.

The proposed device is substantially equivalent because both it and the predicate meet identical indications for use, design principles, and structural composition. Although the motor, controller, and frame material differ, these changes do not raise new safety or effectiveness concerns: the motor upgrade enhances performance, the controller meets the same ISO 7176-14 design requirements with validated software, and the magnesium frame—not in contact with human tissue—provides equivalent structural safety. All biocompatible materials contacting users are identical, and both devices comply with the same comprehensive ISO standards for wheelchairs.