Search Filters

Search Results

Found 29 results

510(k) Data Aggregation

    K Number
    K243749
    Device Name
    Jmoon Conductive Gel
    Manufacturer
    Shenzhen Ulike Smart Electronics Co., Ltd.
    Date Cleared
    2025-04-08

    (124 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Jmoon Conductive Gel is intended to be used with microcurrent devices to improve skin conductivity.
    Device Description
    The Jmoon Conductive Gel is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.
    Ask a Question
    K Number
    K220735
    Device Name
    Avologi Gel Primer (Model: Av25)
    Manufacturer
    Premier North America Inc.
    Date Cleared
    2023-09-15

    (550 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity.
    Device Description
    The Avologi Gel Primer is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.
    Ask a Question
    K Number
    K222770
    Device Name
    Conductive Gel
    Manufacturer
    Top-Rank Health Care Co.,Ltd.
    Date Cleared
    2022-12-13

    (90 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode and the skin.
    Device Description
    Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%. And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The Conductive Gel is used on intact skin surfaces. The entire surface of Conductive Gel is very conductive, smeared evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.
    Ask a Question
    K Number
    K221724
    Device Name
    Conductive Gel
    Manufacturer
    Tone-A-Matic International Inc.
    Date Cleared
    2022-09-23

    (101 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
    Device Description
    Not Found
    Ask a Question
    K Number
    K212325
    Device Name
    EEG-acp
    Manufacturer
    SOMNOmedics GmbH
    Date Cleared
    2022-06-15

    (324 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp.
    Device Description
    EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans (from the age of 2) under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp. It acts as a conductor between the scalp and the cup electrodes to reduce impedance between the electrode surface and the skin. The reduction in impedance facilitates better recording of the signal. It is intended to be used for up to 10 hours after application to healthy, intact skin. After drying, it is self-adhesive and can be washed off with water. The cream is provided non-sterile and in a 100g aluminum tube. It is white and has no adverse smell. Its texture is smooth and creamy directly after withdrawal from the tube, and solid after drying. EEG-acp is intended to be used as an electroconductive medium between the electrode and the patient's skin, i.e., it amplifies the electrical signal and thereby improves the electrophysiological recording. The high salt content of the cream is responsible for its conductive properties. Its impedance is -1.9 kOhm and its conductivity is 20 mS/cm.
    Ask a Question
    K Number
    K212326
    Device Name
    AC Cream - Conductive paste
    Manufacturer
    Spes Medica S.r.l
    Date Cleared
    2021-12-01

    (128 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AC Cream - Conductive paste is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.
    Device Description
    AC Cream - Conductive paste is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. It's characterized by pale yellow colour, no crystallization, no flocculation, bright. AC Cream - Conductive paste function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. AC Cream - Conductive paste is for external use with recording electrodes only. AC Cream - Conductive paste is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Ceteareth-20, Glycerol, Propylene Glycol, Bentonite, Sodium chloride, Potassium chloride, Calcium carbonate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin The pH range is 6÷8, and Impedance at 10Hz is 120± 25 Ohm. The mean impedance after 7 days use, considering the worst values detected, is around 480 ± 10 Ohm. The Conductivity is 20 mS/cm Shelf life of AC Cream - Conductive paste is 3 years if stored properly in the closed packaging, kept away from the sunlight and within the limit temperature
    Ask a Question
    K Number
    K212787
    Device Name
    GT5 conductive & abrasive gel
    Manufacturer
    Wuhan Greentek Pty Ltd.
    Date Cleared
    2021-11-08

    (68 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    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
    K200402
    Device Name
    DR-HO'S Electro Therapy Conductive Gel
    Manufacturer
    Guangzhou Xinbo Electronic Co., Ltd.
    Date Cleared
    2020-11-25

    (280 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DR-HO'S Electro Therapy Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
    Device Description
    DR-HO'S Electro Therapy Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%, And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The DR-HO'S Electro Therapy Conductive Gel is used on intact skin surfaces. The entire surface of DR-HO'S Electro Therapy Conductive Gel is very conductive, sprayed evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.
    Ask a Question
    K Number
    K191975
    Device Name
    Elefix V Paste for EEG & EMG
    Manufacturer
    Nihon Kohden Corporation
    Date Cleared
    2020-02-07

    (198 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elefix V Paste for EEG & EMG is a conductive paste used with surface electrodes to lower skin-electrode impedance. It can be used with electrodes for EEG and EMG examination.
    Device Description
    The Elefix V Paste for EEG & EMG is the electroconductive media used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin. The Elefix V Paste for EEG & EMG is an aqueous based material with Sodium Chloride as the conductive material combined with emulsifiers, humectants and preservatives. The Elefix V Paste for EEG & EMG has been designed to have increased stiffness and improved temperature resistance compared to its predecessor, the predicate device. These changes allow the paste to stay in place better as desired by its users. The Elefix V Paste for EEG & EMG has a neutral pH compared to the slightly alkaline pH of the predicate. The Elefix V Paste for EEG & EMG is available in two models: ZV-401E and ZV-181E. ZV-401E is a container filled with 400 g of the paste. ZV-181E is a tube filled with 180g of the paste. The Elefix V Paste for EEG & EMG is intended to be used by qualified medical personnel within a medical facility. It can be used with electrodes for electroencephalography (EEG) and electromyography (EMG) examination.
    Ask a Question
    K Number
    K192606
    Device Name
    SAC2 - Electrode Cream
    Manufacturer
    Spes Medica S.r.l.
    Date Cleared
    2020-01-17

    (119 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Product Code :

    GYB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.
    Device Description
    SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. SAC2 is provided in an aluminum tube of 100g. It's characterized by light grey colour, no crystallization, no flocculation, no adverse smell, opaque. SAC2 function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. SAC2 is for external use with recording electrodes only. SAC2 is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Talc, Celite, Glycerol, CarboxyMethylCellulose, Sodium chloride, Potassium chloride, Phenoxyethanol, Ehylhexylglycerin The pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm. The Conductivity is 20 mS/cm Shelf life of SAC2 is 3 years if stored properly in the closed aluminum tube kept away from the sunlight.
    Ask a Question

    Page 1 of 3