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510(k) Data Aggregation

    K Number
    K150971
    Device Name
    Zekang Self-adhesive Electrode
    Manufacturer
    Jiangsu Zekang Medical Technology Co., Ltd
    Date Cleared
    2015-08-25

    (134 days)

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

    Jiangsu Zekang Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zekang Self-Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The-Counter) or Prescription use.
    Device Description
    Zekang Self-adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. Zekang Self-adhesive Electrode is composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient multiple application use. Zekang Self-adhesive Electrode has various shapes and sizes. To connect with a nerve or muscle stimulator, this Electrode has lead wire type and snap button type. For lead wire type electrode, the wire is at least 40mm long, with 2.0~3.5mm diameter female socket. For snap button type electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner. The conductive hydrogel is imported from Covidien, USA, which was 510(k) cleared with number of K100418. And the whole Zekang Self-adhesive Electrode together with the conductive hydrogel has again passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.
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