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510(k) Data Aggregation

    K Number
    K240329
    Device Name
    Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)
    Manufacturer
    Yongkang Youha Electric Appliance Co.,Ltd.
    Date Cleared
    2024-03-25

    (49 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

    Device Description

    Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, studies, ground truth, or sample sizes related to the Electric Wheelchair (YHW001-C; YHW001-D; YHW001-E; YHW001-F).

    The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as product classification, general controls, quality system regulations, adverse event reporting, and other compliance requirements.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.

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