Electric Wheelchair (DH01168)

The Electric Wheelchair (DH01168) is a motor-driven, battery-powered four-wheeled vehicle designed to provide indoor and outdoor mobility for disabled or elderly persons limited to a seated position. It features a lithium battery, joystick control, automatic electromagnetic braking, and a foldable design for transport and storage.

The subject device differs from the predicate (K242989) in several parameters: battery capacity (24V, 15.6Ah vs. 24V, 10Ah), maximum load (100kg vs. 120kg), maximum speed forward (5.4 km/h vs. 6.84 km/h), obstacle climbing ability (30-40mm vs. 25mm depending on mode), total mass (40kg vs. 23kg), and wheel sizes. Core design elements including the joystick control method, direct-drive rear-wheel system, and automatic electromagnetic brakes are substantially the same.

ISO 10993-5, 10993-10, 10993-23 (biocompatibility); ISO 7176 series Parts 1-16, 21, 25 (wheelchair safety, stability, performance, batteries, EMC); IEC 60601-1-2:2014+A1:2020 and IEC TR 60601-4-2:2016 (electromagnetic compatibility); ISO 16840-10:2021 (resistance to ignition of postural support devices).

Although there are minor differences in battery capacity, weight, speed, and dimensions, all differing parameters have been tested according to ISO 7176 series standards with results meeting design specifications. The fundamental design, intended use, control method, braking system, and safety characteristics are equivalent to the predicate device, and the minor differences do not negatively impact safety or effectiveness.