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510(k) Data Aggregation

    K Number
    K971948
    Device Name
    PATIENT RESTRAINT
    Manufacturer
    E.M. ADAMS CO., INC.
    Date Cleared
    1997-08-06

    (70 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    E.M. ADAMS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indicated use of these Limb Holders, Mitts and Elbow Splints are to be used as a medical restraint to help prevent patient from pulling and disconnecting other medical devices that are being used in their treatment. These Limb Holders, Mitts and Elbow Splints are intended to be used on hospital beds, wheel chairs, and geriatric chairs. These devices should not be used on extremely violent patients.
    Device Description
    LIMB HOLDERS, MITTS & ELBOW SPLINTS
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    E.M. ADAMS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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