LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022917
    Device Name
    HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
    Manufacturer
    HOME CARE TECHNOLOGY CO., LTD.
    Date Cleared
    2003-03-04

    (182 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES

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

    Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

    Device Description

    Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding self-adhesive electrodes. This type of document is a regulatory approval letter and does not contain information about acceptance criteria, study designs, or performance metrics in the way you've requested for a device evaluation.

    Therefore, I cannot provide the requested information. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical performance criteria or the studies that would typically be described in a clinical or validation report for a novel medical AI device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1