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510(k) Data Aggregation

    K Number
    K132998
    Device Name
    WANDY SELF-ADHESIVE ELECTRODES
    Manufacturer
    WANDY RUBBER INDUSTRIAL CO., LTD
    Date Cleared
    2013-12-20

    (87 days)

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

    WANDY RUBBER INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin, for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.
    Device Description
    Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only. The Wandy Self-adhesive Electrodes 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. The Wandy Self-adhesive Electrodes is used as an accessory with the TENS or EMS device units.
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    K Number
    K031174
    Device Name
    BODY SIGNAL ECG ELECTRODE
    Manufacturer
    WANDY RUBBER INDUSTRIAL CO., LTD
    Date Cleared
    2003-07-10

    (87 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    WANDY RUBBER INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Body Signal ECG Electrodes are designed for use in general electrocardiograph procedures, ordered by a physician, where ECG monitoring is deemed necessary during X-Ray or florescence examination. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording. Body Signal ECG Electrodes are non-sterile products and should not be applied on injured skin surface.
    Device Description
    Not Found
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    K Number
    K002219
    Device Name
    WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
    Manufacturer
    WANDY RUBBER INDUSTRIAL CO., LTD
    Date Cleared
    2001-02-02

    (193 days)

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

    WANDY RUBBER INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002227
    Device Name
    WANDY SILICONE CONDUCTIVE RUBBER PAD
    Manufacturer
    WANDY RUBBER INDUSTRIAL CO., LTD
    Date Cleared
    2001-02-02

    (193 days)

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

    WANDY RUBBER INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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