Ningbo Shenyu Medical Equipment Co.,Ltd · Class II · Cleared Feb 17, 2026
| K-number | K253599 |
| Device name | Electric Wheelchair (W-A807, W-A807L) |
| Applicant | Ningbo Shenyu Medical Equipment Co.,Ltd |
| Product code | ITI |
| Device class | Class II |
| Decision date | Feb 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.3860 |
The Electric Wheelchair (W-A807, W-A807L) is a battery-powered, four-wheeled vehicle designed to provide mobility for disabled or elderly persons who are limited to a seated position. It features joystick control, an aluminum frame, lithium battery power source, and can be used indoors and outdoors.
The subject device uses brushed DC motors (250W, 24VDC) compared to the predicate's brushless motors, has a higher maximum loading weight (136 kg vs 120 kg), improved braking distance (≤1.0 m vs 1.2 m), and a larger battery capacity (24V, 20Ah vs 24V, 13Ah). Both devices share the same wheel count, brake system type, frame material, and overall design methodology.
ISO 7176 series standards (Parts 1-15, 21, 25) covering static/dynamic stability, brake effectiveness, energy consumption, dimensions, maximum speed, obstacle-climbing, electrical safety, electromagnetic compatibility, and battery/charger performance. Also IEC 60601-1-2, IEC 62133-2, ISO 10993-1, and ISO 16840-10.
The proposed device is substantially equivalent because it has the same intended use, classification, and product code as the predicate (K250366). Both comply with identical ISO 7176 standards, and all parameter differences (motor type, battery capacity, speed, weight limits) do not affect safety or effectiveness as demonstrated through comprehensive testing showing equivalent performance across all critical safety measures.
View the full FDA submission: accessdata.fda.gov