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510(k) Data Aggregation

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

    NANMA AJUSTABLE CONSTRICTION RING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the "NANMA Adjustable Constriction Ring." These documents do not contain information about:

    • Acceptance criteria and reported device performance.
    • The specifics of any study conducted to prove the device meets acceptance criteria.
    • Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from these documents. The provided text is purely a regulatory clearance notice based on substantial equivalence, not a summary of performance study results.

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