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510(k) Data Aggregation

    K Number
    K021952

    Validate with FDA (Live)

    Device Name
    HIVOX DREAMATE DM-800
    Manufacturer
    HIVOX BIOTEK, INC.
    Date Cleared
    2003-05-02

    (323 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    used to apply a minor electrical current to electrodes on patient's wrist skin to function as:

    • Helping relieve nausea and vomiting due to motion sickness.
    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "HIVOX DM-800."

    This document does not contain information about:

    1. Specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy).
    2. Details of any study that proves the device meets acceptance criteria.
    3. Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, or training set information.

    The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (helping relieve nausea and vomiting due to motion sickness) and outlines regulatory compliance requirements. It is a regulatory clearance, not a scientific publication detailing performance studies.

    Therefore, I cannot provide the requested table and study details based on the input text.

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