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510(k) Data Aggregation

    K Number
    K140211
    Device Name
    ULTRASONIC MESH NEBULIZER
    Manufacturer
    FOSHAN GAUNYING ELECTRONICS CO., LTD.
    Date Cleared
    2014-05-30

    (122 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN GAUNYING ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital & sub-acute care setting.
    Device Description
    The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.
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    K Number
    K132247
    Device Name
    ULTRASONIC MESH NEBULIZER
    Manufacturer
    FOSHAN GAUNYING ELECTRONICS CO., LTD.
    Date Cleared
    2014-01-08

    (173 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN GAUNYING ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ultrasonic mesh nebulizer model NE105 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital &sub-acute care setting.
    Device Description
    The Ultrasonic Mebulizer NE105 is similar to the predicate device, the FDA-cleared Model NE-U22 Micro Air Vibrating Mesh Nebulizer, cleared under 510(k) K062263. Similarities are that both, the NE105 and the predicate NE-U22, are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating mesh technology to aerosolize liquid medications. They have the same 'Indication for Use' stating that they are for inhalation therapy by adults and pediatric patients in a home, hospital & sub-acute care setting. Both devices are hand-held and portable. Power input for both devices is provided by either AA batteries or an AC/DC adapter. The model NE105 incorporates several design differences in comparison with the predicate NE-U22, mainly body shape, dimension/weight, a larger capacity reservoir, power source and software controlled electronics.
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    K Number
    K121154
    Device Name
    ULTRASONIC NEBULIZER
    Manufacturer
    FOSHAN GAUNYING ELECTRONICS CO., LTD.
    Date Cleared
    2012-08-20

    (126 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN GAUNYING ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ultrasonic mesh nebulizer model NE403 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult patients at home, hospital & sub-acute care settings.
    Device Description
    Nebulizer NE403 is a mesh screen ultrasonic nebulizer which was used ultrasonic Vibrating Mesh Technology ( VMT). The device creates aerosols of liquid medication by ejection of droplets from a mesh vibrated at ultrasonic frequencies. As with other mesh screen ultrasonic nebulizers, the mesh is caused to vibrate by fluidic contact with a ultrasonic piezoelectric member that is energized by application of a high frequency alternating voltage. The VMT nebulizer is portable and quiet. This nebulizer is powered by four AA alkaline batteries or a cable connecting to an AC adapter. Nebulizer NE403 consists of several function units: liquid medication containment, liquid nebulization and ejection, nebulized medicine (brume) channel (breathing parts), power supply, operating and display unit. liquid medication is poured into medicinde container, transformed into something like brume, which is inhaled by patient via breathing parts, thus, the intended use of device is achieved.
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    K Number
    K110721
    Device Name
    GAUNYING INFRARED LAMP
    Manufacturer
    FOSHAN GAUNYING ELECTRONICS CO., LTD.
    Date Cleared
    2011-03-30

    (15 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN GAUNYING ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The infrared lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
    Device Description
    Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is a non-invasive, portable infrared lamp designed to deliver light energy in the infrared spectrum to the target tissue. The light energy is emitted by a built-in Halogen lamp. rated 110-130 Vac. which is enclosed by plastic enclosure, except front panel which is a ceramic / glass plating. Power on/off switch and time setting button is provided in front panel, with which, operator can turn on or off the device and set the treatment time. The treatment time is control by software and shown on the LCD display. The device is connected to mains via a non-detachable power supply with attachment plug. It also includes fuse current, thermal protector and cooling fan as safety component.
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    K Number
    K101693
    Device Name
    GAUNYING INFRARED LAMP MODEL IL50
    Manufacturer
    FOSHAN GAUNYING ELECTRONICS CO., LTD.
    Date Cleared
    2011-01-05

    (203 days)

    Product Code
    ILY, CLA
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN GAUNYING ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gaunying Infrared Lamp ( Model #: IL50) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation.
    Device Description
    Gaunying Infrared Lamp (Model#: IL50) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.
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    K Number
    K102149
    Device Name
    GAUNYING INFRARED LAMP
    Manufacturer
    FOSHAN GAUNYING ELECTRONICS CO., LTD.
    Date Cleared
    2010-08-13

    (14 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN GAUNYING ELECTRONICS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gaunying Infrared Lamp ( Model #: FIR 51, SN-51) are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
    Device Description
    Gaunying Infrared Lamp (Model#: FIR 51, SN-51) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.
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