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510(k) Data Aggregation

    K Number
    K022494
    Device Name
    HOME CARE JELLY
    Manufacturer
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Date Cleared
    2002-12-02

    (126 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HOME CARE JELLY

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

    Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Home Care Jelly," an electroconductive media. It explicitly states that the device is substantially equivalent to legally marketed predicate devices.

    This document is a regulatory clearance letter and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot populate the requested table or answer the questions regarding study details, sample sizes, expert qualifications, or ground truth. The letter's purpose is to grant market clearance based on substantial equivalence, not to present a detailed performance study.

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