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510(k) Data Aggregation

    K Number
    K003284
    Device Name
    PHLEBOPUMP, MODEL 1000
    Manufacturer
    PREVENT PRODUCTS, INC.
    Date Cleared
    2001-01-17

    (90 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREVENT PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K952975
    Device Name
    ANKLE CALF EXERCISER PHLEBOPUMP
    Manufacturer
    PREVENT PRODUCTS, INC.
    Date Cleared
    1996-09-25

    (456 days)

    Product Code
    BXB
    Regulation Number
    890.5380
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREVENT PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACE/PP is intended to exercise the lower leg to help prevent vein thrombosis secondary to venous stasis and blood pooling in the leg. It also retains the exercise function for maintaining muscle tone and preventing stiffness in the ankle joints.
    Device Description
    The ACE/PP is a compact portable exercise device with motor driven foot paddles. The product is controlled by the staff or the patient via an air switch. The paddles are driven in a natural and gentle dorsiflex motion.
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