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510(k) Data Aggregation
K Number
K180773Device Name
Reusable and Self-Adhesive Electrodes
Manufacturer
Date Cleared
2018-05-22
(60 days)
Product Code
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Shaoxing DongZhi Electrical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is an adhesive electrode which is intended for use as the re-usable, conductive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
Device Description
The Reusable and Self-Adhesive Electrodes are made of conductive hydrogel, fabric cloth and carbon film. They work when sticking to human skin and connecting with electrical stimulators by lead wires. During the treatment, electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.
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