| Device Classification Name |
Vehicle, Motorized 3-Wheeled
|
| 510(k) Number |
K252349 |
| Device Name |
Electric Scooter (Mojo-T330) |
| Applicant |
| Dongguan Smarfody Mobility Technology Co., Ltd. |
| Rm. 202, Bldg.2, #9 Junpu Industry 1st Rd. |
| Houjie Town |
|
Dongguan,
CN
|
|
| Applicant Contact |
Alex Wu |
| Correspondent |
| Shanghai SUNGO Management Consulting Co., Ltd. |
| Rm. 1401, Dongfang Bldg., |
| 1500# Century Ave. |
|
Shanghai,
CN
200122
|
|
| Correspondent Contact |
Eva Li |
| Regulation Number | 890.3800 |
| Classification Product Code |
|
| Date Received | 07/29/2025 |
| Decision Date | 01/29/2026 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|