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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?
    Applicant Name (Manufacturer) :

    NANMA MFG CO., LTD.

    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
    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?
    Applicant Name (Manufacturer) :

    NANMA MFG CO., LTD.

    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?
    Applicant Name (Manufacturer) :

    NANMA MFG CO., LTD.

    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?
    Applicant Name (Manufacturer) :

    NANMA MFG CO., LTD.

    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?
    Applicant Name (Manufacturer) :

    NANMA MFG CO., LTD.

    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
    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?
    Applicant Name (Manufacturer) :

    NANMA MFG CO., LTD.

    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
    K993909
    Device Name
    NANMA VACUUM PUMP
    Manufacturer
    NANMA MFG CO., LTD.
    Date Cleared
    2000-07-19

    (245 days)

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

    NANMA MFG CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nanma Vacuum Pumps are external penile rigidity devices designed to promote The Namma Vacuun I umps are extenzi points agency and supers are used to create erections in men with erectile dysfunction.
    Device Description
    Nanma Vacuum Pump
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    K Number
    K993906
    Device Name
    NANMA NON-ADJUSTABLE CONSTRICTION RING
    Manufacturer
    NANMA MFG CO., LTD.
    Date Cleared
    2000-01-31

    (75 days)

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

    NANMA MFG CO., LTD.

    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.
    Device Description
    Nanma non-adjustable constriction ring
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    K Number
    K993908
    Device Name
    NANMA AJUSTABLE CONSTRICTION RING
    Manufacturer
    NANMA MFG CO., LTD.
    Date Cleared
    2000-01-31

    (75 days)

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

    NANMA MFG CO., LTD.

    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.
    Device Description
    Not Found
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