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HG Oxygen concentrator is intended to provide supplemental oxygen to patient continuously in home, hospital or health care facility environments. It is not for supporting or sustaining life.

The subject device, HG Oxygen Concentrator, contains two models, HG5-W and HG5-WN. These two models follow the same design principle, same raw material, same main function and same specification. The only difference between the two models is that HG5-WN oxygen concentrator provide an addition interface on the front panel, which can be connected to the nebulizer and supply air to the nebulizer. The subject device, HG Oxygen Concentrator, is intend to provide ≥90% supplemental low flow oxygen, which is separated from the room air, to the patient in the home, nursing homes, patient care facilities, etc. Oxygen is delivered to the patient via a nasal cannula or oxygen mask, but these accessories are not supplied with the concentrator, the user shall select appropriate and legally marketed accessories themselves. The subject device is not intended to support or sustain life. The subject device, HG Oxygen Concentrator, uses Pressure Swing Adsorption technology to deliver concentrated oxygen. Two chambers and a valve allow compressed air to enter the embedded sieve, which will separate the nitrogen from the air. When one chamber is receiving compressed air, the other is expelling nitrogen back to the air. The cycle is repeated continuously. The concentrated oxygen created at each cycle is stored in an oxygen store cylinder to be delivered to a patient. This working principle is widely used in the oxygen concentrator, it will not arise new question of safety and effectiveness.