Dongguan Smarfody Mobility Technology Co., Ltd. · Class II · Cleared Jan 29, 2026
| K-number | K252349 |
| Device name | Electric Scooter (Mojo-T330) |
| 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 Electric Scooter (Mojo-T330) is a motorized mobility device intended for medical purposes to provide mobility to persons restricted to a sitting position. It features a metal frame with four wheels, a seat, LCD display, electric motor, electromagnetic brake, and rechargeable lithium battery. The device can be folded and has adjustable tilt height and armrest width.
The subject device has four wheels compared to the predicate's three wheels. It has a 24V/200W brushless motor versus the predicate's 48V motor, with a maximum speed of 6.12 km/h versus 5.0 km/h. The battery is 25.9V/10.4AH lithium-ion versus the predicate's 44.4V 2.0Ah. Overall dimensions, weight (23kg vs 18kg), braking distance, stability angles, and obstacle-climbing ability are similar between devices.
ISO 7176 series (parts 1-11, 13-15, 21, 25), ISO 16840-10, IEC 60601-1-2:2014+A1:2020, ISO 10993-1 (biocompatibility), and IEC 62133-2 (battery/charger performance). All testing verified compliance with design specifications and FDA guidance for scooters.
The subject device is substantially equivalent to the predicate because both comply with identical ISO standards, perform similar functions for the same intended use, and demonstrate comparable safety and performance across all tested parameters including stability, braking, range, speed, and dimensional characteristics. Non-clinical laboratory testing shows the subject device meets all design specifications and performs as intended.
View the full FDA submission: accessdata.fda.gov