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510(k) Data Aggregation
K Number
K232020Device Name
Iontophoresis Electrodes
Manufacturer
TOP-RANK Health Care Co., Ltd.
Date Cleared
2023-10-16
(101 days)
Product Code
EGJ
Regulation Number
890.5525Why 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
K160366Device Name
Electrosurgical disposable grounding pads
Manufacturer
TOP-RANK Health Care Co., Ltd
Date Cleared
2016-08-19
(192 days)
Product Code
ODR
Regulation Number
878.4400Why 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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