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510(k) Data Aggregation

    K Number
    K060926
    Device Name
    TRIPOD
    Manufacturer
    FREEDOM DESIGNS, INC.
    Date Cleared
    2006-05-19

    (45 days)

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

    This wheelchair is designed as a transport base for pediatric and adult clients. This device will not diagnose, treat, prevent, oure or pollarity and autor chems. I hus devi users users.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510k clearance letter for a medical device called "Tri Pod", a mechanical wheelchair. The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require a new premarket approval (PMA) application.

    However, the provided document does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or study methodologies.

    Therefore, I cannot answer your specific questions as the relevant data is not present in the provided text. The document is solely an FDA clearance letter and does not include technical specifications or study details.

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