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510(k) Data Aggregation

    K Number
    K222453
    Device Name
    Self-adhesive Electrode
    Date Cleared
    2022-11-04

    (81 days)

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

    Guangdong Comytens Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Self-Adhesive Electrode is intended for as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current),or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
    Device Description
    Self-Adhesive Electrodes are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Comytens are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application: 1. Top layer: Fabric/Foam/ Tan fabric 2. Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film) 3. Bottom layer: Biocompatible self-adhesive conductive hydrogel 4. Connection: Leadwire/snap button/magnetic button 5. double sides adhesive tape: which is used for attaching the non-woven fabrics and conducting film 6. Release liner: plastic film is a protective layer for the hydrogel. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin. For the electrical connection, Comytens provides lead wire type and snap button/Magnetic button type.
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