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510(k) Data Aggregation

    K Number
    K963448
    Device Name
    ECONO BELT
    Manufacturer
    SKIL-CARE CORP.
    Date Cleared
    1996-10-07

    (34 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 Econo Belt is intended for the patient who requires a safety belt while seated in the wheelchair and who requires a reminder not to leave the wheelchair without assistance.

    Device Description

    The Econo Belt is a two-inch-wide, six-foot-long wheelchair safety belt made from nylon webbing. Both ends have sewn loops which can be adjusted in size by means of metal slider buckles. The belt is positioned over the patient's waist, criss-crossed behind the wheelchair, and looped over the kickspurs. It is designed for wheelchair use only .

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document describes a medical device submission (510(k)) for a wheelchair safety belt, detailing its description, indications for use, and comparative information with a previously marketed device. However, it does not include any performance metrics, study designs, or acceptance criteria typical of medical device validation studies.

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