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510(k) Data Aggregation

    K Number
    K990557
    Device Name
    THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR
    Manufacturer
    PDG PRODUCT DESIGN GROUP, INC.
    Date Cleared
    1999-03-22

    (28 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K111636,K163432
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the device is in providing mobility to persons restricted to a sitting position.

    Device Description

    The Stellar Tilt, Manually Operated Wheelchair

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for "The Stellar Tilt, Manually Operated Wheelchair." It is a regulatory approval letter, not a study report, and therefore does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/device performance study.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications and general controls but does not include any performance metrics or study details in the context of your questions.

    Therefore, I cannot extract the requested information from this document.

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