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Justwin Scooter, Model JS-401

by Joy Ride Tech Co., Ltd. 510(k)

Active United States

510(k) K032277

Overview

The Justwin Scooter, Model JS-401 is a motorized three-wheeled vehicle designed to provide mobility for individuals restricted to a seated position. It functions as a powered mobility aid, allowing users to navigate environments independently.

This device is supplied as a reusable, non-sterile motorized scooter intended for use in home and community settings. It is classified as a Class II medical device under FDA regulation 890.3800 with product code INI, and received traditional 510(k) clearance (K032277) on September 24, 2003, based on substantial equivalence to a predicate device.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032277 Date24 Sep 2003ClearedStatusActive

Coverage

1 jurisdiction

United 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 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 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 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 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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

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

Other devices from Joy Ride Tech Co., Ltd.

Questions

  • What is the Justwin Scooter JS-401 used for?

    The Justwin Scooter JS-401 is a motorized three-wheeled vehicle designed to provide mobility for individuals restricted to a seated position, enabling independent navigation in home and community environments as a powered mobility aid.

  • Is the Justwin Scooter JS-401 sterile or single-use?

    The Justwin Scooter JS-401 is supplied as a reusable, non-sterile device, meaning it is intended for repeated use after appropriate cleaning and is not provided in a sterile condition.

  • What regulatory pathway was used for the Justwin Scooter JS-401?

    The Justwin Scooter JS-401 received traditional 510(k) clearance (K032277) on September 24, 2003, based on substantial equivalence to a predicate device under FDA regulation 890.3800 with product code INI.