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510(k) Data Aggregation
(148 days)
The V series Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis in a home, institutional, or travel environment. The device is not intended for life support, nor does it provide any patient monitoring capabilities.
The V series Portable Oxygen Concentrator is intended to release oxygen for respiratory therapy by means of molecular sieve/pressure swing adsorption technology. The machine utilizes the physical principle of pressure swing adsorption with a molecular sieve to adsorb nitrogen and other gas components Device to increase oxygen concentration. It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The V series devices are small, portable and may be used in home, institutional, or travel environment.
The V series Portable Oxygen Concentrator has both pulse mode and continuous mode, there are 6 level/gear settings for pulse mode, and 1 level/gear setting for continuous mode, see the descriptions in the table below:
| Gear Settings | Level 1 (Gear 1) | Level 2 (Gear 2) | Level 3 (Gear 3) | Level 4 (Gear 4) | Level 5 (Gear 5) | Level 6 (Gear 6) | Mode C |
|---|---|---|---|---|---|---|---|
| Rated Flow Rate | 210 mL/min | 420 mL/min | 630 mL/min | 840 mL/min | 1000 mL/min | 1200 mL/min | 1.2 L/min |
The 4 models have the same appearances, intended use, technical characteristics, and working principle, only a difference in gear setting, that is, the 4 models differ in the firmware/software, see the description in table below:
| Models | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 | Level 6 | Mode C |
|---|---|---|---|---|---|---|---|
| V5 | ● | ● | ● | ● | ● | / | / |
| V5C | ● | ● | ● | ● | ● | / | ● |
| V6 | ● | ● | ● | ● | ● | ● | / |
| V6C | ● | ● | ● | ● | ● | ● | ● |
"●" means "standard configuration"; "/" means "do not have the configuration"
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