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510(k) Data Aggregation

    K Number
    K033206
    Device Name
    EPW FOLDABLE POWER WHEELCHAIR, EPW-03
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Date Cleared
    2003-12-18

    (77 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EPW FOLDABLE POWER WHEELCHAIR, EPW-03

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    EPW Foldable Power Wheelchair, EPW-03

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a powered wheelchair, indicating that the device is substantially equivalent to a legally marketed predicate device. It does not include details on performance metrics, study designs, sample sizes, or ground truth establishment.

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