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510(k) Data Aggregation

    K Number
    K041573
    Device Name
    NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
    Manufacturer
    NANMA MFG CO., LTD.
    Date Cleared
    2004-08-25

    (72 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Product Code :

    LKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nanma Vacuum Pump is an external penile rigidity device designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pump is used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)
    Device Description
    Not Found
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    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?
    Product Code :

    LKY

    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
    K030119
    Device Name
    NANMA ADJUSTABLE CONSTRICTION RING
    Manufacturer
    NANMA MFG CO., LTD.
    Date Cleared
    2003-08-06

    (205 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Product Code :

    LKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nanma adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma adjustable constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)
    Device Description
    Not Found
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    K Number
    K030913
    Device Name
    NANMA VACUUM PUMP
    Manufacturer
    NANMA MFG CO., LTD.
    Date Cleared
    2003-06-03

    (71 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Product Code :

    LKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nanma Vacuum Pumps are external penile rigidity devices designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pumps are used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)
    Device Description
    Nanma Vacuum Pump, Model 2M1333
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    K Number
    K013113
    Device Name
    MODIFICATION TO NANMA VACUUM PUMP
    Manufacturer
    NANMA MFG CO., LTD.
    Date Cleared
    2002-12-20

    (458 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Product Code :

    LKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nanma Vacuum Pumps are external penile rigidity devices designed to promote sufficient penile rigidity for sexual intercourse. The vacuum pumps are used to create erections in men with erectile dysfunction. This device is intended for over-the-counter use (OTC)
    Device Description
    Nanma Vacuum Pumps Models 2M995, 2M438 .M330/3R. and 2M265
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    K Number
    K013051
    Device Name
    NANMA ADJUSTABLE CONSTRICTION RING
    Manufacturer
    NANMA MFG CO., LTD.
    Date Cleared
    2002-08-22

    (345 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Product Code :

    LKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nanma constriction rings (adjustable and stretchable) are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)
    Device Description
    Nanma Adjustable and Stretchable Constriction Rings
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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?
    Product Code :

    LKY

    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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    K Number
    K013053
    Device Name
    MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
    Manufacturer
    NANMA MFG CO., LTD.
    Date Cleared
    2002-05-09

    (240 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Product Code :

    LKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nanma non-adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. This device is intended for over-the-counter use (OTC)
    Device Description
    Nanma Adjustable constriction ring
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    K Number
    K020154
    Device Name
    VT-1
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    2002-04-04

    (77 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Product Code :

    LKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
    Device Description
    Not Found
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    K Number
    K020258
    Device Name
    SUPPORT SLEEVE
    Manufacturer
    POS-T-VAC, INC.
    Date Cleared
    2002-04-04

    (69 days)

    Product Code
    LKY
    Regulation Number
    876.5020
    Why did this record match?
    Product Code :

    LKY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to assist users by supporting the penis during intimacy. Used by men with the inability to achieve vaginal penetration, due to a flaccid or partially erect penis.
    Device Description
    Support Sleeve
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