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510(k) Data Aggregation

    K Number
    K252101

    Validate with FDA (Live)

    Device Name
    JWG-1
    Manufacturer
    Yamaha Motor Co., Ltd.
    Date Cleared
    2026-03-19

    (259 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    K203806,K161241
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device JWG-1 is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

    Device Description

    The JWG-1 is an add-on drive for wheelchairs. The JWG-1 turns a manually propelled wheelchair into a powered wheelchair. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

    The device consists of the left/ right drive units, controller, battery and the battery charger. The drive units replace the original wheels of the manual wheelchair.

    Yamaha Li-ion battery JWB3 can be used for the device. They are recharged with the charger JWC4. Battery can be charged in detached 'desktop' condition and on the wheelchair condition. JWB3 does not supply the driving current during the charging to prevent the wheelchair to move.

    AI/ML Overview

    N/A

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