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510(k) Data Aggregation

    K Number
    K023726
    Device Name
    TENS PRO 900
    Manufacturer
    ACUMED MEDICAL SUPPLIES, LTD.
    Date Cleared
    2003-06-17

    (223 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUMED MEDICAL SUPPLIES, LTD.

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

    for use as an adjunct device for the symptomatic relief and management of chronic intractable d. pain

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a regulatory clearance letter and does not contain the information requested about acceptance criteria or a study proving device performance. The letter confirms that the TENS Pro 900 device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. It does not include details on specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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