Electric Wheelchair (DH01126)

The DH01126 Electric Wheelchair is a motor-driven, foldable personal mobility device powered by a lithium-ion battery and controlled via a joystick. It is intended for disabled or elderly individuals with limited mobility, suitable for indoor and outdoor use on flat surfaces near buildings.

The device features two 24V/150W brushless DC motors, a 24V10Ah lithium-ion battery, a carbon-fiber foldable frame, joystick speed control, and hub motor/electromagnetic brake assemblies on rear wheels. Minor differences from the predicate include lower motor power (150W vs 200W), smaller battery capacity (10Ah vs 12Ah), slightly reduced cruising range (12.4 km vs 16.5 km), and lower maximum speed (1.3 m/s vs 1.66 m/s).

ISO 7176 series (parts 1–25) covering stability, braking, energy consumption, dimensions, speed, obstacle climbing, seating, structural strength, control systems, electromagnetic compatibility, and batteries; ISO 10993 series (parts 1, 5, 10, 23) for biocompatibility; IEC 60601-1-2:2020 and IEC 60601-4-2 for electromagnetic safety; and ISO 16840-10:2021/AMD-1 2024 for flame resistance.

The proposed device is substantially equivalent because it shares the same product code (ITI), regulatory classification (Class II), intended use, patient population, and general structure as the predicate Powered Wheelchair (NXN20-209). Although minor differences exist in motor power, battery capacity, and performance metrics, these do not raise new safety or effectiveness concerns because both devices comply with identical ISO 7176 and biocompatibility standards, and nonclinical testing confirmed the subject device performs as intended without adverse effects.