Ningbo Zhishan Medical Technology Co., Ltd. · Class II · Cleared Mar 27, 2026
| K-number | K254206 |
| Device name | Power wheelchair (ZS-EW8026) |
| Applicant | Ningbo Zhishan Medical Technology Co., Ltd. |
| Product code | ITI |
| Device class | Class II |
| Decision date | Mar 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.3860 |
The ZS-EW8026 is a battery-powered, motor-driven wheelchair designed for indoor and outdoor transportation. It provides mobility to disabled or elderly persons who are limited to a seated position, featuring joystick control, automatic electromagnetic braking, and a foldable aluminum alloy frame.
The device has a 24V 20Ah lithium-ion battery, dual 250W brushless DC motors, 6 wheels (2 front driven, 2 rear driving, 2 anti-tips), maximum speed of 6 km/h forward and 0.6 m/s backward, and a maximum loading weight of 150 kg. Minor differences from the predicate include shorter braking distance (0.7m vs. 1.0-1.2m), slightly higher maximum backward speed, and higher maximum loading weight.
ISO 7176 series (parts 1-11, 13-15, 21-22, 25), ISO 16840-10:2021 (resistance to ignition), IEC 60601-1-2 and IEC 60601-4-2 (EMC), IEC 62133-2:2017 (lithium battery safety), and FDA's 2023 Biocompatibility Guidance. Risk analysis per ISO 14971:2019 and software validation were also conducted.
The subject device is substantially equivalent to the predicate K250158 Electric Wheelchair because both comply with identical ISO standards, perform similarly across all tested parameters (stability, braking, speed, dimensions, electrical safety), use comparable control systems and materials, and minor differences in specifications do not raise new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov