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Indications For Use: The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen.

The Oxlife Independence Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. Patients may include but are not restricted to those with chronic obstructive pulmonary disease (COPD). The device is not intended to be life sustaining or to be life supporting. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are nonsterile. The Oxlife Independence Oxygen Concentrator provides approximately 90% oxygen to the patient on continuous to 3 and on a conserver flow basis at an "equivalent" rate of 1.0 liters per minute to 6.0 liters to minute. The Oxlife Independence Oxygen Concentrator is capable of continuous use in a home, institution, vehicles and various mobile environments. Power options include 110-220 VAC, 12-14 VDC or rechargeable batteries. The Oxlife Independence Oxygen Concentrator uses molecular sieve adsorption technology. Ambient air is drawn thru particle filters by a compressor and forced thru molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from molecular sieve, allowing it to adsorb again during next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a valve, and timers are used to make the system function. Oxygen is delivered to the patient on a continuous flow basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Oxlife Independence Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, thru a final filter, into the connected nasal cannula and onto the patient. The design of the Oxlife Independence Oxygen Concentrator has focused on maximizing efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight and battery operation for mobile use. The basic technology of the Oxife Independence Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device noted in the submission.

The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

The OxLife Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home, automobile or institution without a continuous source of purified oxygen. They are not life-supporting nor life-sustaining devices. The devices operate through the use of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. The compressor creates a vacuum to suck room air through a pre-filter and HEPA filter into a holding tank. At the same time, downstream of the compressor, the air from the previous cycle is pressurized into one of the two aluminum welded molecular sieve tanks. As the oxygen is forced out of the end of the tank, it enters a "T" fitting that directs most of the gas to flush the nitrogen out of the second molecular sieve tank into the ambient air. The remaining oxygen is delivered to the patient. On the next cycle, the air is directed into the second molecular sieve tank with the oxygen generated flushing the first tank and continuing the supply to the patient. This repetitive cycle generates the oxygen necessary to flush and prepare the saturated sieve tank while supplying the patient with a continuous flow of high concentration oxygen. All models have inverter capability to use a 12 Volt DC power as well as 110v.