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The Invacare Flyer (Model XPO100) is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.

The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institutional environment or in a vehicle or other mobile environment. The device is not intended to sustain or support life. The device is used with a nasal cannula to direct oxygen from the device to the patient. The Invacare Flyer provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6%. Standard power options include an AC to DC switching power supply operating from AC power outlet (120 VAC/ 60 Hertz nominal), a DC to DC switching power supply operating from accessory outlets typically found in a mobile vehicle type environment (12 VDC nominal) and an external rechargeable battery. The Invacare Flyer uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath. The basic technology of the Invacare Flyer is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the noted predicate device.

The Invacare Twilight Full Face Mask is intended to be used with positive airway pressure (PAP) devices, such as CPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adult obstructive sleep apnea. There is a port on the mask to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.

The Twilight full Face Mask consists of a mask that fits over the nose and mouth of a patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose and mouth. The cushion mounts to a rigid clear plastic frame. The frame has built in exhalation ports, a full swivel for locating the pressure device hose, a tubing swivel to allow for twisting of the hose, and a built in anti-asphyxia valve to allow the inner volume of the mask to be open to the outer atmosphere when there is no pressure being supplied by the flow generator device. Mounted to the frame is an adjustable forehead support for resting against the patient's forehead. The headgear has quick release clips and loop adjustment on the straps.

To assist persons who have difficulty rising from a seated position to a standing position.

The EasyStand Evolv is a modular standing frame for indoor use that allows users with various degrees of physical disability to be supported in a standing, weight-bearing position. The device is modular and is configured around a centralized seat. It incorporates pivot points that allow a user to rise from a fully seated to a fully standing position. Pivot action is such that shear the user, seat and seat back is minimized. Device is modular in that multiple uses of the device can be accommodated depending on the overall configuration of the device. Current modules allow for passive standing (Basic), workstation use at an elevated or seated position (Shadow Support Tray) and standing with leg exercise (Glider). Elevation action is provided by one of two means. The standard device utilizes a user controlled hydraulic pump. The optional electrical version uses a low voltage motor-driven linear actuator that is powered by two 12-Volt batteries and actuated by a hand held control pendant. On the electrical version, the patient or a care provider activates the hand held control pendant to change the position of the seat. The electric version also provides an emergency release. Recharge of batteries is accomplished by connection of an external battery charger to the control pendant. The EasyStand Evolv is designed for indoor use and will accommodate individuals ranging in height from 5' to 6'2" (152cm - 188 cm) and up to 280lbs (127kg)

The Invacare Model Twilight II Nasal Mask is intended to be used with positive airway pressure devices such as CPAP, for the treatment of adult obstructive sleep apnea. There is a port on the mask swivel to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.

The Invacare Twilight II Nasal Mask is a prescription device intended for use with positive airway pressure devices. It is intended to provide single or multiple patient use/reuse for the delivery of respiratory therapy to adult patients (>30 Kg) with obstructive sleep apnea in a sleep lab or home care setting. It is designed for use with positive airway pressure devices having pressure ranges from 3-20 cmH2O. The Invacare Twilight II Nasal mask consists of a mask that fits over the nose of the patient and headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A small, standard and a large cushion are designed for use with the same mask. This also allows for replacement of a worn or damaged cushion without the need to replace the entire mask. The cushion mounts into a rigid polycarbonate shell by means of a flanged area that fits snugly between the wall of the mask shell and an inner retaining ring that is permanently mounted into the shell. The mask includes an opening that accepts a standard, flexible, 22mm (outside diameter) breathing tube. The breathing tube is connected to the output of the positive airway pressure device and to the input of the Invacare Twilight II Nasal Mask. The mask is then placed over the user's nose. The flexible tube provides a transition between the more rigid output tube of the delivery device and the mask, thus allowing fr3eedom of movement while maintaining patient circuit integrity. The Invacare Twilight II Nasal Mask can be reused on multiple patients by disinfecting the mask according to provided instructions. Following cleaning with Enzol® enzymatic cleaning detergent, the mask is disinfected u sing a Cidex OPA solution or STERRAD Disinfection System. Testing has shown the mask can be disinfected 30 times without loss of effectiveness.

The intended function of the tilt/recline seating system is for repositioning and/or weight shift for pressure relief for individuals who cannot do this independently due to injury or disability. The elevate function is intended primarily to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility. The Invacare 3G Tarsys is rated for a combined user and accessory weight of 300 pounds. The tilt only and recline only versions are rated for a combined user and accessory weight of up to 400 pounds. The seating system is intended to be used with power wheelchair bases for which it is found to be compatible.

The Invacare 3G Tarsys is a battery powered, motorized seating system designed for use with power wheelchairs. The seating system is rated for 300 pounds. Tilt only and recline only versions are rated for 400 pounds. An electrically operated linear actuator drives the tilt and recline functions with weight balance maintained through the stability of the base. The recline function incorporates a mechanical sliding back mechanism to reduce back shear as well as optional power elevating leg rests. The elevate function is driven by an electrically operated linear ball screw actuator mounted in a vertical fashion and allows the seat to be elevated to a maximum of 7" ± .25". The tilting, reclining and elevating systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline/elevate system, a combination of tilt/recline, tilt/elevate or as separate tilt only, elevate only systems depending on the user's needs. The joystick in conjunction with the Tilt Recline Elevate Control Mechanism (TRECM) and the Invacare MK V EX controller activates the power positioning modules.

The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA). The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort.

The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA). The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort. The addition of heated humidification relieves the drying and irritating effects on the patient airways, which may result from the use of a CPAP system.

The intended function and use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30kg.) for the treatment of Obstructive Sleep Apnea (OSA).

All units consist of a flow generator (blower), patient circuit, exhalation port, humidifier (if desired), microprocessor based control system, pressure sensor and operate on 120 volts AC, 60Hz

To provide mobility to persons limited to a seated position.

The Invacare Adventure Series of Scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to persons limited to a seated position. The scooters are basic conventional rear wheel drive, rigid frame vehicles that are battery powered. Various options and accessories are available depending upon user needs and preferences. They consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They also include a tiller handle for steering and a throttle control to engage and disengage the scooter motion in both the forward and reverse directions. The scooters can also be disassembled for ease of transport, are powered by two (2) 12 volt DC batteries, and utilize an on-board charger. The scooters have a status indicator located on the face of the control panel that provides diagnostic information. The status LED will flash a certain number of times, separated by a pause when a fault is detected in the controller or in the wiring. This feature is for diagnostic information only and does not control the operation of the scooter. The Adventure SX-3 is a compact version of the scooter with a 250 lb. weight capacity while the Adventure LX-3 scooter is a mid-size version of the scooter with a 350 lb. weight capacity.

The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmH2O for the treatment of adult obstructive sleep apnea. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single patient use.

The Twilight nasal mask is a prescription device intended for use with Continuous Positive Airway Pressure (CPAP), and Bi-Level devices. It is intended to provide a single patient use interface for the delivery of CPAP or Bi-Level therapy to adult patients (>30Kg). It is designed for use with CPAP and Bi-Level delivery systems having pressure ranges from 3-20 cmH2O. The Twilight nasal mask consists of a mask that fits over the nose of the patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A standard and a large cushion are designed for use with the same mask. This also allows for replacement of a worn or damaged cushion without the need to replace the entire mask. The cushion mounts into a rigid polycarbonate shell by means of a flanged area that fits snugly between the wall of the mask shell and an inner retaining ring that is permanently mounted into the shell. The mask includes an opening that accepts a standard, flexible, 22cm OD breathing tube. The breathing tube is connected to the output of the CPAP/Bi-Level delivery device, and to the input of the Invacare Twilight Nasal Mask. The mask is then placed over the users' nose and mouth. The flexible tube provides a transition between the more rigid output tube of the delivery device, and the mask, thus allowing freedom of movement while maintaining patient circuit integrity.

The intended use of the Invacare Model Storm TDX Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

The Invacare Storm TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or "non- folding" type power wheelchair, with mid wheel drive capability.