Zhejiang Nysin Medical Co., Ltd. · Class II · Cleared Jan 29, 2026
| K-number | K252275 |
| Device name | Electric Scooter (DDF100) |
| Applicant | Zhejiang Nysin Medical Co., Ltd. |
| Product code | INI |
| Device class | Class II |
| Decision date | Jan 29, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.3800 |
The Electric Scooter (DDF100) is a motorized three-wheeled vehicle designed to provide indoor and outdoor mobility to disabled or elderly persons limited to a seated position. It features two front wheels, two rear wheels, two rear anti-tip wheels, a seat with back and arm supports, an adjustable steering column, tiller console, electric motor, electromagnetic brake, and rechargeable lithium-ion battery.
The design and technological characteristics are similar to the predicate devices. Key components include an electromagnetic brake that engages automatically when not in use and can be manually adjusted to free-wheel mode, a speed lever and steering column for movement control, and a rechargeable lithium-ion battery with off-board charger. The scooter operates only on flat roads.
EN 12184:2022, ISO 7176 series (Parts 1-15 and 22), and ISO 16840-10:2021. These standards cover electrical safety, static and dynamic stability, brake effectiveness, energy consumption, dimensions and mass, maximum speed, seating dimensions, structural strength, climatic performance, obstacle-climbing ability, power and control systems, labeling, and fire resistance.
The subject device is substantially equivalent because it is a motor-driven indoor/outdoor transportation vehicle with identical indications for use as predicate devices (K201196 and K242982). All parameters with differences do not raise safety or effectiveness concerns based on performance testing to ISO 7176 series standards. The differences do not introduce new issues of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov