Nanjing Kangni Smart Technology Co., Ltd. · Class II · Cleared Dec 5, 2025
| K-number | K252494 |
| Device name | Electrically powered wheelchair (KZ301B) |
| Applicant | Nanjing Kangni Smart Technology Co., Ltd. |
| Product code | ITI |
| Device class | Class II |
| Decision date | Dec 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.3860 |
The Electrically powered wheelchair (KZ301B) is a motor-driven vehicle designed for indoor and outdoor use to provide mobility to disabled or elderly persons who are limited to a seated position. It features a foldable frame, joystick control, automatic electromagnetic braking, and lithium-ion batteries.
The subject device uses an iron main frame (vs. aluminum in predicate), brushless DC motors (vs. brush DC), and has slightly different dimensions, weight (35 kg vs. 25 kg), maximum speed (5.9 km/h forward vs. 5.47 km/h), turning radius (950 mm vs. 600 mm), and maximum incline capability (9° vs. 6°). Both devices share the same wheel configuration, joystick control, electromagnetic brake system, and obstacle-climbing ability (40 mm).
ISO 7176 series (Parts 1-15, 21-22, 25), ISO 16840-10:2021 (flame retardancy), IEC 60601-1-2:2020 (electromagnetic compatibility), and ISO 10993-1 (biocompatibility).
The subject device is substantially equivalent because it has identical intended use, same design principles for controller and driving system, and all differences in specifications and materials (frame material, motor type, dimensions, speed, incline) do not raise new safety or effectiveness concerns as both devices meet the same ISO 7176 safety standards and requirements.
View the full FDA submission: accessdata.fda.gov