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510(k) Data Aggregation

    K Number
    K963413
    Device Name
    MULTIPLE LIMB HOLDERS
    Manufacturer
    J. T. POSEY CO.
    Date Cleared
    1996-11-14

    (76 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MULTIPLE LIMB HOLDERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These products are intended to limit limb movement or finger movement in a hospital bed or gurney.

    Device Description

    The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the bed or gurney via straps. These straps are securely connected to the bed, genatic chair, or wheelchair by one or more of the following: knots, corset buckles, keyed lock buckles, square rings, hook and loop, standard buckles, or quick release buckles.

    AI/ML Overview

    This document describes a 510(k) submission for protective restraints (limb holders) by T. T. Posey Co. It does not describe an AI/ML device or any study that would involve acceptance criteria, performance metrics, ground truth, or expert review in the context of AI/ML.

    Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a medical device (protective restraints) that has been on the market for a long time, not a submission for a new AI/ML-driven diagnostic or therapeutic device.

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