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510(k) Data Aggregation

    K Number
    K240840
    Device Name
    Oxygen Concentrator (ZY-10AB/115)
    Manufacturer
    Foshan Care Medical Technology Co., Ltd.
    Date Cleared
    2024-12-06

    (254 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Foshan Care Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.
    Device Description
    The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 10L/min. The nasal cannula are not sold with the device, users need to purchase the accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4, and it is not recommended to use humidification bottles. The maximum altitude the subject device can operate without degradation of concentration is 2000m.
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    K Number
    K130001
    Device Name
    CARE SU01A SUCTION ASPIRATOR
    Manufacturer
    FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2013-07-25

    (204 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CARE SU01A Suction aspirator is intended for professional use to remove infectious materials from wounds or fluids from a patient airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.
    Device Description
    The SU01 A Suction aspirator is designed to provide general suction for use in hospitals or clinics. This Suction aspirator is a professional medical suctioning device that produces a maximum vacuum of 560 mmHg. It is used with a power supply allowing operation on AC voltage (120 VAC, 60 Hz). The device is equipped with 850ml collection bottle and has been designed for convenient and reliable and reliable usages. The vacuum pump of the SU01A transmits negative pressure throughout the tubing-system and the collection bottle to patient tubing that aspirates secretions or liquid form the body. The vacuum pump can be manually adjusted using the regulating value and the vacuum gage. The aspirated fluids are collected in the collection bottle that is isolated from the pump by a bacteria filter. It also has a mechanical overflow protection in the lid of the collection bottle to further prevent the fluids from being sucked into the pump.
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    K Number
    K101552
    Device Name
    FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001
    Manufacturer
    FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2011-03-14

    (283 days)

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

    FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Foshan Care Medical Nebulizer Compressor, Model K Y WH2001, includes an AC powered air compressor that provides a source of compressed air. The compressor is used in conjunction with the Hsiner Disposable Nebulizer, Model Number HS-31100, to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The Foshan Care Medical Nebulizer Compressor, Model KY WH2001 is intended to aerosolize physician- prescribed solutions for inhalation that are approved for nebulization. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001 is intended for adult and pediatric patients consistent with the indications for the aerosol medication. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001, is not intended for life support nor does it provide any patient monitoring capabilities.
    Device Description
    Not Found
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    K Number
    K102245
    Device Name
    CARE ZY5BA OXYGEN CONCENTRATOR
    Manufacturer
    FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
    Date Cleared
    2010-11-09

    (92 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CARE ZY5BA Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The CARE ZY5BA Oxygen Concentrator is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.
    Device Description
    The CARE ZY5BA is an AC power electrically operated device. The unit separates oxygen from room air (ambient air), which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room. It will not affect the normal amount of oxygen in user's room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized valve and protected from over pressurization by the compressor's pressure relief valve. Oxygen provided by the CARE ZYSBA Oxygen Concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or oxygen mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy. The front panel of the CARE ZY5BA contains the controls and indicators. These include the status lights (included power light, normal oxygen light, low oxygen light and service required light), standard power switch, flow meter and the flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc). The user could operate the device conveniently according the instructions.
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