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510(k) Data Aggregation

    K Number
    K963768
    Device Name
    INSTANT HOT PACKS
    Manufacturer
    KICK ICE, INC.
    Date Cleared
    1996-11-25

    (67 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    KICK ICE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device provides instant hot treatment used for first aid purposes to reduce local pain and discomfort.
    Device Description
    INSTANT HOT PACK
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    K Number
    K963666
    Device Name
    INSTANT COLD PACK
    Manufacturer
    KICK ICE, INC.
    Date Cleared
    1996-10-30

    (47 days)

    Product Code
    IMD
    Regulation Number
    890.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    KICK ICE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device provides instant cold treatment used for first aid purposes to reduce minor local pain, swelling and discomfort.
    Device Description
    The Kick Ice pack consists of a bag containing Ammonium Nitrate and a liquid bubble bag containing water. The Ammonium Nitrate in the water produces a chemical reaction- When pressure is applied to the inner bubble through the outer bag the inner bubble of water opens up mixing it with the Ammonium Nitrate thereby producing cold. The material for the bag will consist of either polyester, or laminated polyethylene.
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