Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K171381
    Device Name
    Adhesive Electrodes
    Manufacturer
    ShenZhen Quality Medical Technology Co.,Ltd
    Date Cleared
    2017-12-13

    (216 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    ShenZhen Quality Medical Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.
    Device Description
    The Adhesive Electrodes transmit electrical current to patient skin, the electrical current is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin. Adhesive Electrodes are multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application: EVA foam First layer: Insulating backing material: Second layer: Conductive film: Carbon film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET. The dimension of the adhesive electrode is 40 mm (L) × 70 mm (W) ×3mm (H).
    Ask a Question

    Page 1 of 1