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510(k) Data Aggregation
K Number
K033405Device Name
LONGFEI LFY-I-5 OXYGEN CONCENTRATOR
Manufacturer
ZHEJIANG LONGFEI INDUSTRIAL CO., LTD.
Date Cleared
2005-10-18
(725 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
ZHEJIANG LONGFEI INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LFY-I-5 Oxygen Concentrators are indicated fro the administration of supplemental oxygen. The LFY-I-5 Oxygen Concentrators are not intended for life support nor does it provide any patient monitoring capabilities.
Device Description
The Longfei Model LFY-I-5 Oxygen concentrator is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. Its intended function and use 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. 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, if desired. 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 LFY-I-5 Oxygen concentrator is a 5-liter per minute oxygen concentrator that is of the pressure swing adsorption (PSA) type. The pneumatic system consists of 5 major components: inlet filtration, air compressor and heat exchanger, synthetic Zeolite molecular sieve beds and distribution value module, outlet filtration, and flow meter. The electrical system consists of AC power distribution to the air compressor and a motor with gear reduction used to drive the distribution valve; the unit is double insulated and uses a two-conductor power cable. Device monitoring circuit are included that monitor oxygen concentration. In the event of a malfunction, the unit will shut down and activate visual.
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