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510(k) Data Aggregation

    K Number
    K032776
    Device Name
    VACURECT VACUUM CONSTRICTION DEVICE
    Manufacturer
    VACURECT MANUFACTURING (PTY) LTD.
    Date Cleared
    2003-10-03

    (25 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    VACURECT MANUFACTURING (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction.
    Device Description
    The Vacurect Vacuum Constriction Device is an over the counter device that consists of two main components: the vacuum tube and the constriction ring. The vacuum tube consists of the pump sleeve, spacer ring, dome/sleeve O-Rings, dome/valve stopper, and vacuum ring. The Vacurect Vacuum Constriction Device works by creating a vacuum in the vacuum tube. This is accomplished by moving the pump sleeve up and down along the vacuum tube. The flexible rubber constriction ring when placed onto the vacuum tube (open end), forms an airtight seal with the vacuum tube. Once the opening of the constriction ring is placed on the penis head, the vacuum chamber is sealed and operation of the pump sleeve will immediately draw the penis into the vacuum tube. Once the required penis rigidity is reached. the vacuum pump mav be removed and the ring can remain on the penis for up to 30 minutes.
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    K Number
    K020969
    Device Name
    VACURECT VACUUM CONSTRICTION DEVICE
    Manufacturer
    VACURECT MANUFACTURING (PTY) LTD.
    Date Cleared
    2002-06-05

    (71 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    VACURECT MANUFACTURING (PTY) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vacurect vacuum component is intended to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis. The constriction ring is intended to maintain penile rigidity in men with erectile dysfunction. The Vacurect Vacuum Constriction Device is intended for over-the-counter use.
    Device Description
    The Vacurect Vacuum Constriction Device is an over the counter device that consists of two main components: the vacuum tube and the constriction ring. The vacuum tube consists of the pump sleeve, spacer ring, dome/sleeve O-Rings, dome/valve stopper, and vacuum ring. The Vacurect Vacuum Constriction Device works by creating a vacuum in the vacuum tube. This is accomplished by moving the pump sleeve up and down along the vacuum tube. The flexible rubber constriction ring when placed onto the vacuum tube (open end), forms an airtight seal with the vacuum tube. Once the opening of the constriction ring is placed on the penis head, the vacuum chamber is sealed and operation of the pump sleeve will immediately draw the penis into the vacuum tube. Once the required penis rigidity is reached, the vacuum pump may be removed and the ring can remain on the penis for up to 30 minutes.
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