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510(k) Data Aggregation

    K Number
    K121531
    Device Name
    A&J 5L POCA SERIES OXYGEN CONCENTRATOR
    Manufacturer
    ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
    Date Cleared
    2012-07-17

    (54 days)

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

    ZHONGSHAN A&J MEDICAL EQUIPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A&J 5L POCA series Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy at home, in nursing homes, at patient care facilities. A&J 5L POCA series is available by prescription only under the supervision of a physician.
    Device Description
    A&J 5L POCA series Oxygen concentrator is AC power electrically operated. 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 your 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 value and protected from over pressurization by the compressor's pressure relief value. Oxygen provided by the A&J 5L POCA series Oxygen concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy. The front panel of the A&J 5L POCA series Oxygen concentrator contains the controls and indicators. These include the status lights (included power light, normal oxygen light, fow oxygen light and service required light), standard power switch, 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 to the instructions.
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    K Number
    K071608
    Device Name
    A&J POCA01 OXYGEN CONCENTRATOR
    Manufacturer
    ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
    Date Cleared
    2008-01-11

    (213 days)

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

    ZHONGSHAN A&J MEDICAL EQUIPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A&J-POCA01 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 A&J-POCA01 is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.
    Device Description
    The A&J-POCA01 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 A&J-POCA01 is available by prescription only under the supervision of a physician, and is not intended to support or sustain life. The A&J-POCA01 is an AC power electrically operated. 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 your 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 value and protected from over pressurization by the compressor's pressure relief value. Oxygen provided by the A&J-POCA01 Oxygen Concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy. The front panel of the A&J-POCA01 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, a 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 operated the device conveniently according the instructions.
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    K Number
    K071607
    Device Name
    ASA01 HEAVY DUTY SUCTION PUMP
    Manufacturer
    ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
    Date Cleared
    2007-06-26

    (14 days)

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

    ZHONGSHAN A&J MEDICAL EQUIPMENT CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASA01 Heavy Duty Suction Pump is a vacuum suction device designed to remove bodily fluids from the patients' airway or respiratory support system. It is intended for use by trained personnel under the direction of the physician.
    Device Description
    The ASA01 Heavy Duty Suction Pump is an AC-powered, stand-alone device, designed to collection of nonflammable fluid materials in medical applications.
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