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510(k) Data Aggregation

    K Number
    K994266
    Device Name
    FDTENS 2010
    Manufacturer
    FUJI DYNAMICS LIMITED
    Date Cleared
    2000-07-06

    (202 days)

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

    FDTENS 2010

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

    TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drugfree pain management unit. The TENS system is designed for the treatment of pain - chronic, acute or post-operative pain.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the FDTENS 2010 device, a Transcutaneous Electrical Nerve Stimulation (TENS) unit. The document states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for the FDTENS 2010.

    Therefore, I cannot populate the requested table or answer the specific questions about the study design or results. The document is solely a regulatory clearance letter, not a performance report or study summary.

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