Zhejiang Taotao Vehicle Co., Ltd. · Class II · Cleared Dec 4, 2025
| K-number | K252588 |
| Device name | Mobility Scooter (T5) |
| Applicant | Zhejiang Taotao Vehicle Co., Ltd. |
| Product code | INI |
| Device class | Class II |
| Decision date | Dec 4, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.3800 |
The Mobility Scooter (T5) is a motor-driven indoor and outdoor transportation vehicle designed to provide mobility to disabled or elderly persons limited to a seated position. It is classified as a Class II motorized three-wheeled vehicle under regulation 21 CFR 890.3800.
The subject device features a 24V 350W motor with Li-ion battery (25.6Vdc 15Ah), maximum speed of 7.92 km/h, maximum loading of 150kg, and a minimum turning radius of 2175mm. Key differences from the predicate include a foldable tiller with removable basket versus foldable seat, 9-inch tires versus 15-inch, and slightly different ground clearance (20mm vs 45mm). The device dimensions are 1240mm×610mm×875mm with a total mass of 54kg.
ISO 7176 series standards (parts 1-16, 21-22, and 25) covering stability, braking, range, dimensions, seating, durability, ignition resistance, EMC, and battery/charger performance. Additionally, ISO 10993-1 for biocompatibility and IEC 60601-1-2:2014+A1:2020 for electromagnetic compatibility.
The subject device is substantially equivalent to the predicate device (K231428, W3431D Scooter) because both comply with identical ISO 7176 standards and FDA guidance for scooters, perform similarly in all critical safety and performance parameters (stability, braking, range, dimensions), and demonstrate equivalent test results across all ISO 7176 test categories. Non-clinical laboratory data confirms the subject device performs as intended under specified use conditions.
View the full FDA submission: accessdata.fda.gov