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510(k) Data Aggregation

    K Number
    K232020
    Device Name
    Iontophoresis Electrodes
    Manufacturer
    TOP-RANK Health Care Co., Ltd.
    Date Cleared
    2023-10-16

    (101 days)

    Product Code
    EGJ
    Regulation Number
    890.5525
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOP-RANK Health Care Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
    Device Description
    The proposed device is indicated for the administration of soluble salts or other drugs into the body for medical purposes. The Iontophoresis Electrodes utilize adhesive electrodes have both anode and cathode electrodes that adhere to the skin. The electrodes may either be connected by leads (wires) to a separate controller Forming a current loop. The portion of the active electrode that contacts the skin also has a drug/solution reservoir. End users saturate the reservoir with the ionic solution to be delivered. The reservoir contacts the electrode and the drug/solution is delivered to the patient transdermally. Five models (Small, Medium, Large, Butterfly and Return Electrode) are included in this series products, and they have the same intended purposes, working theories and specifications.
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    K Number
    K160366
    Device Name
    Electrosurgical disposable grounding pads
    Manufacturer
    TOP-RANK Health Care Co., Ltd
    Date Cleared
    2016-08-19

    (192 days)

    Product Code
    ODR
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOP-RANK Health Care Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.
    Device Description
    Electrosurgical disposable grounding pads construct of a layer of conductive aluminum foil with a foam as the supportive base of the pad. The aluminum foil is coated with adhesive hydro-gel layer. There is another film placed above the adhesive hydro-gel layer, which is used to protect the gel during the transportation and storage and will be removed prior to use. They are available in different combinations of configurations, types, intended populations and conductive area. They are not provided in sterile conditions and not required to be sterilized by the end user prior to operation. However, they are for single use only.
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