Search Results

The SIMEOX 200 airway clearance device is intended to promote airway clearance and to improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough. SIMEOX 200 is intended for use in the home, hospital, and other healthcare institutions by individuals weighing at least 23 Kg.

The SIMEOX 200 Airway Clearance Device consists of a portable generator and a single patient use expiratory kit. The patient inhales from the ambient environment, naturally and independent of the device, and then exhales into the device mouthpiece. During the patient's exhalation, the SIMEOX 200 generates a pneumatic vibration throughout the airway. This vibration, applied at 6 Hz or 12 Hz via negative pressure pulses, disseminates throughout the bronchial tree in order to decrease mucus viscosity and increase secretion mobility. During or after therapy, the patient can clear the secretions by coughing independently.

The Inogen Rove 6 Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in the home, institution, and transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

The Inogen Rove 6 Portable Oxygen Concentrator (Inogen Rove 6) is a Class 2, low risk, portable oxygen generator that provides a high concentration of supplemental oxygen to patients requiring respiratory therapy on a prescriptive basis. It may be used in home, institution, vehicle, and other transport modalities. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non-sterile. The Inogen Rove 6 Portable Oxygen Concentrator is capable of continuous use in a home, institution, vehicle, and various mobile environments. Power options include 100 - 240 V-AC (50-60Hz) power supply, rechargeable battery packs, or a 13.5 -15.0 V-DC power cable. The Inogen Rove 6 Portable Oxygen Concentrator uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function. Oxygen is delivered to the patient on a pulse dose 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. The Inogen Rove 6 Portable Oxygen Concentrator senses the beginning of the inhalation cvcle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient. The Inogen Rove 6 Portable Oxygen Concentrator utilizes Bluetooth technology that pairs the portable oxygen concentrator to a mobile device or tablet using the Inogen Connect App.

The Inogen At Home Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen At Home Oxygen Concentrator may be used in a home or institution.

The Inogen At Home is a stationary concentrator providing approximately 90% oxygen to patients on a continuous flow basis at a rate of 1.0 liter per minute (LPM) to 5.0 liters per minute (LPM), in 1.0 liter per minute (LPM) increments. Nasal cannula channels oxygen from device to patient; both concentrator and nasal cannula are non-sterile. The device is capable of continuous use in the home or in an institutional setting. The Inogen At Home can be powered by mains AC power found in the home or in an institutional setting. The Inogen At Home includes a detachable AC power cord to make the electrical connection to the AC mains. The Inogen At Home utilizes Pressure Swing Adsorption (PSA) technology to produce oxygen. Oxygen is separated from ambient air under pressure by molecular characteristics and affinity for adsorbent material. The molecular sieve preferentially adsorbs nitrogen, allowing enriched oxygen to collect in an accumulator; the process then swings to low pressure to desorb the nitrogen, exhausting it back into the environment. A series of sieve beds, manifold with precision valves, sensors, and embedded software are used collectively to govern system functionality.

The Inogen One Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Inogen One Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments.

The Inogen One 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 non-sterile. The Inogen One Oxygen Concentrator provides approximately 90% oxygen to the patient on a demand flow basis at an "equivalent" rate of 1.0 liters per minute to 5.0 liters to minute in increments of 0.5 liters per minute. The Inogen One 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 Inogen One Oxygen Concentrator uses molecular sieve / pressure swing adsorption technology. Ambient air is drawn thru particle filters by a compressor and forced thru molecular sicve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a manifold with precision valves, sensors and embedded software to control the cycle are used to make the system function. Oxygen is delivered to the patient on a demand 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. Inogen One 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 Inogen One Oxygen Concentrator has focused on maximizing subsystem 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 Inogen One Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device noted in the submission.