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510(k) Data Aggregation

    K Number
    K192739
    Device Name
    Electric Wheelchair [Models: JRWD6010/JRWD6012]
    Date Cleared
    2021-07-13

    (652 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jerry Medical Instrument (Shanghai) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
    Device Description
    The proposed device, Electric wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The electric wheelchair consists of two foldable armrests, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The electric wheelchair is intended to provide mobility to a person with a disability or an older adult limited to a sitting position.
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    K Number
    K192658
    Device Name
    Manual Wheelchair
    Date Cleared
    2020-04-01

    (189 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jerry Medical Instrument (Shanghai) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    The proposed device, Manual Wheelchair, driven by manual operation of rear tire, or pushed by caretaker. This product is mainly designed to be used to take care of the disabled or elderly, it is driven by manual operation of rear tire, or pushed by caretaker. The Manual Wheelchair consists of Frame, Footplate, Front castor, Rear wheel, Anti-tipper, Armrest, Brake, Central fork. The Manual Wheelchair has four models: JR201, JR202, JR203, JR204.
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