LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC.

    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
    Ask a Question

    Page 1 of 1