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510(k) Data Aggregation

    K Number
    K991508
    Device Name
    ACUMASTER BRAND ACUPUNCTURE NEEDLE
    Manufacturer
    HELIO MEDICAL SUPPLIES, INC.
    Date Cleared
    1999-08-27

    (120 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACUMASTER BRAND ACUPUNCTURE NEEDLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an acupuncture needle. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical or performance study summary.

    Therefore, I cannot extract the requested information to fill the table and answer the questions. The document's purpose is to grant market clearance based on substantial equivalence to a predicate device, not to detail device performance studies against specific acceptance criteria.

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