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Electric Scooter Mojo-T580

by Dongguan Smarfody Mobility Technology Co., Ltd. EUDAMED510(k)

Active European Union and United States

510(k) K252347

Overview

The Electric Scooter Mojo-T580 is a motorized three-wheeled vehicle designed for personal transportation. Classified as a motorized three-wheeled vehicle under regulatory frameworks, it operates using electric power for mobility assistance and short-distance travel.

This device is intended for outdoor use and is supplied as a reusable, non-sterile product. It has received FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for motorized mobility aids. The Mojo-T580 is not intended for medical therapy but falls under the Physical Medicine advisory committee classification for administrative filing purposes.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252347 Date29 Jan 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

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

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Questions

  • Is the Mojo-T580 designed for indoor or outdoor use, and what are its primary intended applications?

    The Mojo-T580 is explicitly designed for outdoor use as a motorized three-wheeled vehicle. While it provides mobility assistance, it is not intended for medical therapy. Instead, it serves as a personal transportation solution for short-distance travel, falling under the regulatory classification of a motorized mobility aid.

  • How is the Mojo-T580 supplied, and is it reusable or single-use?

    The Mojo-T580 is supplied as a reusable, non-sterile product. Since it is not intended for clinical or medical use, it does not require sterilization between users. Proper maintenance and care are recommended to ensure safe and prolonged use.

  • What regulatory pathways has the Mojo-T580 followed, and which advisory committee was involved in its review?

    The Mojo-T580 has received FDA 510(k) clearance and MDR authorization, demonstrating compliance with regulatory standards for motorized mobility aids. Its review was conducted under the Physical Medicine (PM) advisory committee, which oversees submissions related to physical medicine devices, though the device itself is not classified as a medical therapy tool.

  • Does the Mojo-T580 come in multiple sizes or models, and if so, how are they differentiated?

    The provided data does not specify distinct sizes or models for the Mojo-T580. However, the device is listed under product code INI and includes multiple registration numbers, which may correspond to variations or regional compliance requirements. For exact specifications, consulting the manufacturer’s documentation or contacting Dongguan Smarfody Mobility Technology Co., Ltd. would be necessary.