Search Results
Found 2 results
510(k) Data Aggregation
K Number
K212787Device Name
GT5 conductive & abrasive gel
Manufacturer
Wuhan Greentek Pty Ltd.
Date Cleared
2021-11-08
(68 days)
Product Code
GYB
Regulation Number
882.1275Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Greentek Pty Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. GT5 conductive & abrasive gel is not intended for use with stimulating electrodes.
Device Description
GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance (resistance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. The electrical activity of the brain is transferred to the electrode and then to EEG instruments and computer equipment. GT5 conductive & abrasive gel is for use with external electrodes only.
GT5 conductive & abrasive gel is an off-white color, opaque, no adverse smell gel with sodium chloride as the conductive material combined with thickening agents, emulsifiers, humectants, preservatives and abrasive particles. With the abrasive particles in the gel, the gel can be also used as skin preparation by being applied to the skin surface to rub the skin lightly in order to reduce skin impedance efficiently and increase signal quality recorded with EEG electrodes.
The composition of GT5 conductive & abrasive gel is as follows:
Glycerin, Sodium chloride, Water, Methylparaben, Sodium Carboxymethyl cellulose, Alkyl indican, Aluminum Oxide.
The pH range is 6.5-7.5, and the impedance at 10Hz is 0.2K Ohm or less. The conductivity is 18±0.5 mS/cm. GT5 conductive & abrasive gel is available in the following sizes: a pre-filled syringe of 20g, a tube of 100g, a bottle container of 473g, a bottle container of 946g. Shelf life is 3 years if stored properly, i.e. kept with containers tightly closed and at room temperature.
Ask a Question
K Number
K200162Device Name
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
Manufacturer
Wuhan Greentek Pty Ltd.
Date Cleared
2020-04-21
(90 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Greentek Pty Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
Device Description
Disposable EEG Electrodes includes three models: DL, E-CAP, FLEX-CAP. The models E-CAP and FLEX-CAP are EEG electrode positioning systems used to place a number of EEG electrodes in a uniform and consistent manner on the head in order to transmit electrophysiological signals from an individual to data collection devices. The model E-CAP is made from spandex type material with silver/silver chloride-plated ABS electrodes in silicone base attached to the cap. The model FLEX-CAP is made from spandex type material with silver/silver chloride ink printed electrodes on PET in silicone base attached to the cap, the cap covering the entire scalp and is held in place with chin straps. The spandex type material holds the electrodes securely in position during an EEG recording. The electrodes on the caps connect to the EEG equipment either through an adapter cable or in some instances, special connector on match EEG equipment. The electrical activity of the brain is transferred via the electrolyte to the electrode and then to the EEG equipment for evaluation. The models E-CAP and FLEX-CAP have been built with the placement of 2-128 electrodes, the size of cap is from 26 to 66 cm. The model DL is a silver/silver chloride-plated ABS electrode with shrink tubing and connector, which is used on the model E-CAP. In addition, model DL can be used alone on the scalp for EEG monitoring. The electrodes on the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) are positioned according to the International Ten-Twenty System (10-20) of Electrode Placement. In addition, Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) with as a few as 2 or as many as 128 electrodes, have been mounted in a place according to the 10-10 American Electroencephalographic Society positioning system. Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) can also be custom-made, in which the numbers of electrodes and placement of electrodes are made under an instruction from customs.
Ask a Question
Page 1 of 1