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510(k) Data Aggregation

    K Number
    K032441
    Device Name
    F-10 FOLDING POWER CHAIR
    Manufacturer
    WHEELCHAIR & SCOOTER EXPRESS
    Date Cleared
    2003-10-06

    (60 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

    To provide an optional means of mobility for physically challenged people.

    Device Description

    F-10 Folding Power Chair

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (F-10 Folding Power Chair), which is a regulatory submission to demonstrate substantial equivalence to a predicate device. It is not a study report demonstrating the device meets specific acceptance criteria based on performance metrics such as sensitivity or specificity.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in the provided document. The document primarily focuses on the regulatory approval process and the determination of substantial equivalence for the powered wheelchair to a legally marketed predicate device.

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