Mojo-T330 Electric Scooter
by Dongguan Smarfody Mobility Technology Co., Ltd. EUDAMED510(k)
Active
510(k) K252349
Overview
The Mojo-T330 is a motorized three-wheeled vehicle designed for personal mobility. Classified as a motorized three-wheeled vehicle, it is intended for outdoor use as a means of transportation, providing an alternative to traditional bicycles or motorcycles for short-distance travel.
This device is supplied as a reusable, non-sterile product and is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR). It is intended for use in outdoor environments and does not require MRI safety considerations. The device is authorized for distribution in the United States and the European Union, with registration numbers and product codes listed in regulatory databases.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK252349 | Date29 Jan 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Electric Scooter (Mojo-T330)
- 510(k) Number
- FDA Product Code
- INI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dongguan Smarfody Mobility Technology Co., Ltd.
See all devices from Dongguan Smarfody Mobility Technology Co., Ltd. →
Questions
What is the primary intended use of the Mojo-T330 electric scooter and where can it be used?
The Mojo-T330 is designed as a motorized three-wheeled vehicle for personal mobility, serving as an alternative to bicycles or motorcycles. It is specifically intended for outdoor use as a means of transportation, ideal for short-distance travel in non-indoor environments.
Is the Mojo-T330 a single-use or reusable device, and what does that mean for maintenance?
The Mojo-T330 is a reusable device, meaning it is not meant to be discarded after a single use. This classification implies that it is built for durability and can be cleaned and maintained for repeated use, though the manufacturer’s guidelines should be followed for proper upkeep.
Does the Mojo-T330 require any special storage conditions, and is it sterile?
The Mojo-T330 is explicitly described as a non-sterile product, so it does not require sterile storage conditions. However, it should be stored in a dry, protected environment away from extreme temperatures or moisture to ensure optimal performance and longevity.
What regulatory pathways has the Mojo-T330 followed for approval in the U.S. and EU?
The Mojo-T330 has obtained FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent under the Physical Medicine advisory committee. In the EU, it complies with the Medical Device Regulation (MDR), though no specific clinical indication is provided beyond its classification as a motorized three-wheeled vehicle for outdoor mobility.
Are there multiple models or sizes available for the Mojo-T330, and how would one identify them?
The provided data lists multiple registration numbers (e.g., 3033905189, 3012604975) under the product code INI, which may correspond to different variants or batches of the Mojo-T330. However, no explicit details on size variations or model distinctions are given in the data. For precise specifications, refer to the manufacturer’s documentation or contact support.