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510(k) Data Aggregation

    K Number
    K182111
    Device Name
    DL Self-adhesive Electrode
    Manufacturer
    Shaoxing DL Healthcare Co., Ltd.
    Date Cleared
    2019-01-17

    (164 days)

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

    Shaoxing DL Healthcare Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DL 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
    DL Adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin. DL Adhesive Electrode is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate) or LDPE(Low Density Polyethylene). DL Adhesive Electrode is non-sterile and intended for single adult patient multiple application use. The Adhesive Electrode has various shapes and sizes. To connect with a nerve or muscle stimulator, DL Electrode pads have lead wire type or snap button type. The lead wires have female sockets, while the snap buttons have male connectors. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) carrier liner. The conductive hydrogel is imported from Covidien, USA, we used the same conductive hydrogel as the Self-Adhering TENS/NMES/FES Stimulating Electrode which was 510(k) cleared with number of K100418. Further, our entire Adhesive Electrode together with the conductive hydrogel media has passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.
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