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510(k) Data Aggregation

    K Number
    K090007
    Device Name
    JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000
    Manufacturer
    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
    Date Cleared
    2009-07-24

    (203 days)

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

    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended function and use of the Jumao Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
    Device Description
    The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator. The output of oxygen is 0.5 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of adsorption material - molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed bottom. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the bottom of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 90% oxygen to the patient. Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used with the JM-07000i/ JM-07000 models, if desired. The JM-07000Hi model incorporates the Humidifier to provide humidified oxygen to the user. The Humidiflow attaches to the inlet of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas. The Humidifier has been cleared by FDA (K062091). The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch. The basic technology of the JuMao oxygen concentrator is equivalent to the other approved oxygen concentrator. The principles of operation are equivalent to the noted predicate device, Invacare Platinum 5 Oxygen Concentrator by Invacare Corporation, 510(k) K020386.
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    K Number
    K082784
    Device Name
    JUMAO MANUAL WHEELCHAIR
    Manufacturer
    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
    Date Cleared
    2008-10-07

    (14 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Jumao Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The Jumao Manual Wheelchair is an indoor/outdoor wheelchair that has a base with four-wheels with a seat. The device can be disassembled for transport and it is foldable easily. Both the back and seat upholstery material is the same resistance-ignitability fabric.
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