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510(k) Data Aggregation

    K Number
    K181234
    Device Name
    Self-adhesive Electrode
    Date Cleared
    2018-08-07

    (90 days)

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

    Dong Guan Ou Kang Electronics CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.
    Device Description
    Self-adhesive electrode is available in Lead wire type and snap type. Both types are composed of a non-woven fabric, a double side adhesive tape, conducting film, hydrogel and plastic film. The construction difference is the lead wire or snap. It functions as a passive device by carrying an electrical signal from a stimulation device through the device cable and electrode lead wire or snap to the user skin.
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