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Power Mobility Scooter (MJMA01, MJMA02)

by Nanjing Mijo Technology Co., Ltd EUDAMED510(k)

Active European Union and United States

510(k) K253936Ref MA05Model Go Go Twist

Overview

This device is a Vehicle, Motorized 3-Wheeled, designed to assist individuals with limited mobility in indoor and outdoor environments. It provides powered propulsion for users who require enhanced mobility support, enabling independent movement with minimal physical effort.

The Power Mobility Scooter (MJMA01, MJMA02) is intended for single-use or reusable applications in clinical and home settings, depending on configuration. It has received FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for Class II devices under product code INI. No specific sterility or MRI safety information is provided in the data.

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

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697807460PMS001RG Basic UDI-DIDate2 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253936 Date12 Mar 2026ClearedStatusActive

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: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k)

Model / Reference
Go Go Twist, MA05
FDA applicant
Nanjing Mijo Technology Co., Ltd.
Primary DI / UDI-DI
06978074600218
Basic UDI-DI
697807460PMS001RG
510(k) Number
FDA Product Code
INI
EMDN Code
Y122124 Electric scooters
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 890.3800
Market of Registration
Spain
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
510(k)
Class II

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Questions

  • What environments is the Power Mobility Scooter (MJMA01, MJMA02) designed to operate in?

    The Power Mobility Scooter (MJMA01, MJMA02) is specifically designed to assist users with limited mobility in both indoor and outdoor environments. Its powered propulsion system enables independent movement in a variety of settings, reducing physical effort for the user.

  • Is the Power Mobility Scooter (MJMA01, MJMA02) intended for single-use or reusable applications?

    The Power Mobility Scooter (MJMA01, MJMA02) is configurable for either single-use or reusable applications, depending on the clinical or home setting requirements. This flexibility allows for tailored use based on patient needs and facility policies.

  • What regulatory pathways has the Power Mobility Scooter (MJMA01, MJMA02) followed, and what class does it fall under?

    The Power Mobility Scooter (MJMA01, MJMA02) has received FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for Class II medical devices under product code INI. The device was determined to be substantially equivalent through a traditional review process by the Physical Medicine Advisory Committee.

  • Are there any specific models or variations of the Power Mobility Scooter (MJMA01, MJMA02) available, and how are they differentiated?

    The device is available in two distinct models: MJMA01 and MJMA02. While the provided data does not specify technical differences between them, the models are likely designed to cater to varying user needs, such as weight capacity, maneuverability, or additional features, though exact distinctions would require further consultation with the manufacturer.

  • Does the Power Mobility Scooter (MJMA01, MJMA02) require any special storage conditions, and is it sterile upon delivery?

    The provided data does not specify any special storage conditions for the Power Mobility Scooter (MJMA01, MJMA02). Additionally, there is no mention of sterility requirements or whether the device is supplied in a sterile state, so users should confirm these details with the manufacturer or facility protocols before use.

Properties

Show properties
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No