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510(k) Data Aggregation
K Number
K230969Device Name
Oxygen Concentrator
Manufacturer
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
Date Cleared
2023-11-09
(218 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JUMAO Oxygen Concentrator is intended 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
JMC5A Ni oxygen concentrator is made up of mainframe and flowmeter. It is an electronically operated device that separates oxygen from ambient air. It provides high concentration of oxygen directly to patient/user through a nasal cannula or other methods.
The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator which takes 120V ~ power source as power source. 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 93% oxygen to the patient.
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K Number
K200466Device Name
Manual Wheelchair (Model W28)
Manufacturer
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
Date Cleared
2021-06-14
(474 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The W28 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Device Description
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. The device is intended for adults only.
W28 is a mechanical wheelchair including four wheels, a steel frame cover black paint and a textilene upholstery that is flame resistant. W28 has a physical dimension of 1100mm × 908mm (depth × width × height) with the seat itself has a dimension of 415mm × 500mm × 475mm (depth × height). The device has a weight capacity of 136 kilograms, and weighs about 20.5 kilograms. The color is dark black.
Occupant mass group of the manual wheelchair belongs to III. Armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle.
The components include frame, back upholstery, seat upholstery, handgrip, armrest, armrest pad, side panel, rear wheel, handrim, wheel lock, caster, caster fork, footrest, footplate.
Main materials: Steel (frame, armrest, wheel lock, caster fork, footrest, footplate), PVC (handgrip, side panel, handrim, caster, back upholstery, seat upholstery, armrest pad, rear wheel)
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