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510(k) Data Aggregation

    K Number
    K971536
    Device Name
    RESTRAINTS (VESTS AND JACKETS)
    Manufacturer
    E.M. ADAMS CO., INC.
    Date Cleared
    1997-07-01

    (64 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The indicated use of these Vests and Jackets is to be used as a mild restraint. To help prevent the patient from falling, sliding or getting out of bed. The Vests and Jackets can be used in a hospital bed, wheelchair or geriatric chair. These Vests and Jackets should not be used on violent patients.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter and an "Indications For Use" statement for a medical device: Restraints (Vests and Jackets). This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, or comparative effectiveness studies.

    The letter is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices, which allows the manufacturer to market the product. It primarily focuses on regulatory compliance rather than clinical performance data from studies.

    Therefore, I cannot fulfill your request for the specific details outlined, as they are not present in the provided text.

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