Dongguan Smarfody Mobility Technology Co., Ltd. · Class II · Cleared Jan 29, 2026
| K-number | K252347 |
| Device name | Electric Scooter (Mojo-T580) |
| Applicant | Dongguan Smarfody Mobility Technology Co., Ltd. |
| Product code | INI |
| Device class | Class II |
| Decision date | Jan 29, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.3800 |
The Mojo-T580 is an electric scooter designed to provide mobility for persons restricted to a sitting position. It features a four-wheeled frame with a motor, electromagnetic brake, lithium battery, and manual folding capability, controlled by a rider-operated lever and speed knob on flat surfaces.
The subject device has four wheels compared to the predicate's three wheels. It features a 24V/200W brushless motor and 25.9V/10.4AH lithium battery with slightly higher forward speed (6.12 km/h vs 5.0 km/h) and shorter braking distance (1200mm vs 500mm). Overall dimensions and weight are similar, with comparable stability, obstacle-climbing, and range characteristics.
ISO 7176 series (parts 1-15, 21, 25, 31), ISO 10993-1 (biocompatibility), ISO 16840-10 (resistance to ignition), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), and IEC 62133-2 (battery/charger performance).
The subject device is substantially equivalent to the predicate because both comply with identical ISO 7176 standards and FDA guidance for scooters. Performance testing demonstrates equivalence in static/dynamic stability, brake performance, range, dimensions, speed, and safety characteristics. Non-clinical laboratory data support that the subject device performs as intended with similar safety and efficacy profiles.
View the full FDA submission: accessdata.fda.gov