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510(k) Data Aggregation

    K Number
    K050691
    Device Name
    R. POON MEDICAL PRODUCTS WHEELCHAIRS
    Manufacturer
    R. POON MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2005-04-21

    (35 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

    R. Poon Medical Products Co., Ltd. Wheelchairs are intended to be used to provide mobility to persons restricted to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) premarket notification letter from the FDA to R. Poon Medical Products Co., Ltd. regarding their wheelchairs. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information about:

    • Acceptance criteria for a device's performance.
    • A study proving a device meets acceptance criteria.
    • Performance metrics, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    It focuses solely on the regulatory approval process for a mechanical wheelchair, not on the technical performance evaluation of an AI/ML-based device as implied by your detailed request.

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