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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO NANMA VACUUM PUMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a 510(k) clearance letter for the Nanma Vacuum Pump. It does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the same way a PMA or de novo submission might.

    Therefore, I cannot provide the requested information from this document. The document primarily confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the Nanma Vacuum Pump is substantially equivalent to legally marketed predicate devices for the indicated uses.

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