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510(k) Data Aggregation

    K Number
    K172358
    Device Name
    Instalief
    Manufacturer
    Privi Medical Pte Ltd
    Date Cleared
    2018-01-10

    (160 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.
    Device Description
    Instalief™ is a device designed for the treatment of internal and external hemorrhoids by the application of cold directly to the swollen hemorrhoidal tissue. The device consists of an outer bag which houses an endothermic salt, a smaller water-containing frangible bag, an insertion tip with an attached compliant balloon, as well as a separate component that aids in the usage of the device, known as the squeezer. To use the device, the user first bursts the frangible bag by pressing on it, initiating an endothermic process between the water and endothermic salt. The user then inserts the shaft of the device into the anal canal (for internal hemorrhoids) or applies to the outer tissues (for external hemorrhoids), and squeezes the bag with the aid of the squeezer. This action transfers the cold fluid generated into the balloon, which provides targeted cold therapy to the hemorrhoids. Instalief™ is meant to be used for 6 - 8 minutes.
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    K Number
    K113660
    Device Name
    COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
    Manufacturer
    CRYOTHERAPY PRODUCTS INC.
    Date Cleared
    2012-05-03

    (142 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device use is the treatment of hemorrhoids by applying it directly to the swollen Hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The cap section is used for the treatment of external hemorrhoids and the tube section for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the tube into the rectum.
    Device Description
    Not Found
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    K Number
    K072414
    Device Name
    CRYOSTAT
    Manufacturer
    LIL DRUG STORE PRODUCTS, INC.
    Date Cleared
    2008-04-07

    (223 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is for the treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. By applying the device to the tissue, the inflammation is reduced. The direct application of cold provides prompt relief of/extinguishes itching, burning, pain, and swelling. In addition, the device is beneficial for the treatment of perianal fissures due to the vasoconstriction and analgesia properties of the device.
    Device Description
    The Cryostat Cold Therapy Pack device consists of a combination of water and chemicals in an anatomically designed sealed plastic bag, enclosed in a cloth outer wrapper for comfort. Six Cold Therapy Packs are packaged in one carton. An individual cold pack is 95mm long and 25mm wide and 26mm in depth. A cold pack consists of a series of inner plastic containers, one of which contains water and FDA food grade dye (to distinguish it from the other fluid), inside a second container which contains a secondary fluid, consisting of water, USP Food grade Kosher propylene glycol as well as a different color FDA food grade dye. The freezing temperature of the first fluid is higher than that of the second fluid. This allows a time released cooling process which delivers high performance cold therapy because of conduction and convection following the phase change of the primary fluid from solid to liquid. The containers are made of formable film common in the food and medical packaging industry. The film is a multi-layer extrusion with one layer being Nylon to add strength and act as a vapor barrier. Visual inspection is performed to verify seal integrity and the dye in the fluids facilitates quality control. Since the intended use of the device is to treat a specific ailment which requires comfort, the miniature cold pack is then wrapped in a heat sealable fabric for comfort to the affected area. The material chosen is white, so that the device, once used can be seen as soiled and therefore is disposed of.
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    K Number
    K042564
    Device Name
    HEMOR-RITE CRYOTHERAPHY
    Manufacturer
    FAMA HOLDINGS INTERNATIONAL CORP
    Date Cleared
    2005-09-30

    (374 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device use is for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying the device to the tissue, the inflammation is reduced. The base section is used for the treatment of external hemorrhoids and the neck/probe section is used for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the probe into the rectum.
    Device Description
    Hemor-Rite Cryotherapy is an anatomically designed device for applying cold therapy (Cryotherapy) directly to the swollen hemorrhoidal veins of external hemorrhoids and the internal hemorrhoids within the rectal cavity. The direct application of cold provides prompt relief of itching, pain, and swelling. In addition, Hemor~Rite Cryotherapy is beneficial for the treatment of anal and perianal fissures due to the vasoconstriction and analgesia properties of the device. Hemor-Rite Cryotherapy has been designed taking the following factors into consideration: human anatomy and the medical concepts for treating the ailment. Hemor-Rite Cryotherapy is an anatomically designed medical device ergonamicly shaped for application of cold therapy (Cryotherapy) directly to swollen hemorroidal veins of external hemorrhoids and internal hemorthoids within the rectal canal. The direct application of cold provides prompt relief of itching, pain, and swelling. The device consists of a sealed applicator containing a coolant formula. The Hemor~Rite device is placed into the user's freezer until frozen. After the Hemor-Rite Cryotherapy device is frozen, the user inserts the device to te affected hemorrhoidal area. The probe is maintained in the area for 6-8 minutes, until the probe reaches body temperature, or up to a maximum of 10 minutes. The Hemor~Rite Cryotherapy device is a reusable device. Hemor~Rite is comprised of two pieces of plastic; the crown and the base.
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    K Number
    K012746
    Device Name
    ICE BATON
    Manufacturer
    BEHIVE LTD
    Date Cleared
    2001-11-14

    (90 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ice Baton is intended to provide relief from pain and discomfort due to hemorrhoids
    Device Description
    The Ice Baton is a suppository-shaped medical device designed to provide relief from the pain and discomfort due to hemorrhoids. The Ice Baton consists of an applicator cover and applicator. During use, the cover is removed and the Ice Baton applicator is filled with bottled or drinking water. The applicator cover is placed back on the Ice Baton and excess water is removed. The Ice Baton is placed in the user's freezer until frozen. After the Ice Baton is removed from the freezer, the applicator cover is removed and the Ice Baton is applied to the target hemorrhoid area. It is maintained on that area until the ice has melted or relief is felt. The Ice Baton is a disposable device.
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    K Number
    K981428
    Device Name
    ANU ICE
    Manufacturer
    CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC.
    Date Cleared
    1998-07-07

    (78 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device use is the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal Tissues. By applying cold to the tissue, the INFLAMMATION IS REDUCED -THE CAP SECTION IS USED FOR THE TREATMENT OF EXTERNAL HEMORRHOIDS AND THE TUBE SECTION FOR THE TREATMENT OF INTERNAL HEMORRHOIDS. THE LUBRICANT IS USED TO EASE THE INTRODUCTION. OF THE TUBE INTO THE RECTUM.
    Device Description
    ANUICE -COLD PACK, PLASTIC APPLICATO MEDICAL GRADE - NON-CHOMICA
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    K Number
    K973590
    Device Name
    HEMORRELIEF DEVICE
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1998-02-05

    (136 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemorrelief device is intended to provide treatment for the relief of pain, itching, inflammation and bleeding of hemorrhoids by means of cryotherapy (controlled cold treatment).
    Device Description
    Not Found
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