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510(k) Data Aggregation
K Number
K160081Device Name
TENS Electrodes
Manufacturer
CATHAY MANUFACTURING CORP.
Date Cleared
2016-10-19
(278 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
CATHAY MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators. i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for OTC use.
Device Description
The proposed TENS Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The proposed device mainly consists of electrode pad and wire. The electrode pad is available in rectangular shape, round shape, and butterfly shape, etc.
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K Number
K130027Device Name
DISPOSABLE NEUTRAL ELECTRODE GP202
Manufacturer
CATHAY MANUFACTURING CORP.
Date Cleared
2013-08-22
(231 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CATHAY MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This disposable neutral electrode for adult patients with conductive adhesive gel is used as neutral reference during electrosurgical procedures.
Device Description
The Disposable Neutral Electrode, is an accessory for high voltage high frequency electrosurgical devices, connect it to the body of the PATIENT and the HF SURGICAL EQUIPMENT, it can perform it function for provide a return path for the HIGH FREQUENCY current and unwanted burns are avoided. Construction --- The product consists of Electrode carrier and Clarity PET. It is packed in an al film bag. The electrode is composed of conductive gel, aluminum foil, sponge, anti-sticking film and connecting wire. Conductive gel is composed of high molecular monomer, glycerinum and water, which is a gel, can be conducted in high frequency and has voltage-sensitive by polymerization.
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