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The Invacare® Platinum® 5NXG Oxygen Concentrator is indicated for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.

The subject Invacare® Platinum® 5NXG Oxygen Concentrator device is used by patients who require supplemental oxygen. The device is not intended to sustain or support life. The oxygen concentration level of the output gas ranges from 87% to 96% at an output flow rate range of 1 to 5 liters per minute (LPM). The oxygen is delivered to the user through the use of a nasal cannula. The concentrator provides supplemental oxygen to patients with respiratory disorders, in the home, long term care facility or other non-acute patient care facilities. It is not intended to sustain or support life. It is to be used indoors and is intended to support the patient's lifestyle within the home or care facility. The device operates at a nominal 120VAC/60 Hertz supply.

The Invacare AVIVA Storm RX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.

The subject device is a rearward drive wheel version substantially equivalent to the previously cleared forward drive wheel Invacare® AVIVA FX Power Wheelchair (K192216) with LiNX Electronics and Ultra Low Maxx Seating System. The subject device version consists of the following changes: - . Rearward drive wheel placement - . Modification to suspension system - . Modification to battery box design and seat interface brackets - Minor changes to mechanical components such as new rims and colors . The Invacare® AVIVA Storm RX Power Wheelchair is a 24V DC system, motor-driven wheelchair, utilizing the predicate device LiNX® control system. The subject device consists of a rigid or "non-folding" type power wheelchair base with rearward drive wheel placement with two (2) casters in the front and two anti-tippers in the rear. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.

The Invacare® Perfector™V Oxygen Concentrator is indicated for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.

The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare® Perfecto2™V Oxygen Concentrator. The subject device is used by patients who require supplemental oxygen concentration level of the output gas ranges from 87% to 95.6% at an output flow rate range of 1/2 to 5 liters per minute. The oxygen is delivered to the user through the use of a nasal cannula.

The Invacare® AVIVA FX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.

The subject device is a front wheel drive version of the existing previously cleared Invacare TDX SP2 (Center Wheel Drive) Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The subject version of the Invacare TDX SP2 Power Wheelchair consists of the following changes: Alternative Front Wheel Drive Base, Seating Brackets to connect the Ultra Low Maxx Seating System to the base, Wiring Harness to connect the LiNX controller, the AVIVA FX base and the Ultra Low Maxx Seating System. The Invacare® AVIVA FX Power Wheelchair is a 24V DC battery-powered, motor-driven wheelchair, utilizing the predicate device LiNX® Control System and Ultra Low Maxx Seating System. The subject device consists of a rigid or "non-folding" type power wheelchair base with front wheel drive with 2 casters in the rear and two anti-tippers in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.

Invacare® Platinum® Mobile Oxygen Concentrator: The Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home. The device is not intended to be life supporting or life sustaining. Invacare Mobile Medical Application Accessory PICCOLO O2: The Invacare Mobile Medical Application Accessory PICCOLO O2 is intended to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/servicing purposes.

The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare Mobile Medical Application Accessory Piccolo O2 which is compatible with the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator, cleared under K160630 on September 27, 2016. Invacare Mobile Medical Application Accessory PICCOLO O2 is a Mobile App is intended to provide useful device performance information to the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator end users such as dosage level setting and fault codes as well as allow the user to control the selected dosage level. - . Invacare® Platinum® Mobile Oxygen Concentrator with Connectivity - . Invacare Mobile Medical Application Accessory for Piccolo O2 use on iOS and Android devices - POC1 USB Bluetooth Dongle .

The indication for use of the Invacare® TDX® SP2-HD with Captain's Seat is to provide mobility and positioning to persons limited to a sitting position.

The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes: - Increase in the weight capacity of the previously cleared device from 300 lb to 450 lb. Invacare® TDX® SP2 Power Wheelchair is a battery-powered, motor-driven powered wheelchair, controlled by the LiNX® control system with enhanced suspension and additional back, arm and leg rest types. The subject device is a rigid or "non-folding" type power wheelchair base with center-wheel drive capability, two casters in the rear and two casters in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors. No new accessories were added to the new device.

The Invacare® Solara® 3G Manual Wheelchair and Invacare® Solara® 3G Spree Manual Wheelchair are intended to provide mobility to adults limited to a sitting position.

The Invacare® Solara® 3G Manual Wheelchair is an attendant operated and self-propelled, mechanical wheelchair for adults. The indication for use of the Invacare® Solara® 3G Manual Wheelchair is to provide mobility to adults limited to a sitting position. The indication for use of the Invacare® Solara® 3G Spree Manual Wheelchair is to provide mobility to person limited to a sitting position. These devices are rigid, "non-folding" type wheelchairs that incorporate a solid seating surface (seat pan).

The indication for use of the Invacare® TDX® SP2 Power Wheelchair is to provide mobility and positioning to persons limited to a sitting position.

The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K141783) with the MK6i™ control system and Formula™ CG Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes: - . The LiNX® control system, which incorporates updated software, wireless technology and a touch user interface, - The Ultra-Low Maxx™ Seating System, and ● - Minor changes to mechanical components such as rim inserts and new colours. . The TDX® SP2 Power Wheelchair is a battery-powered, motor-driven powered wheelchair, controlled by the LiNX® control system with enhanced suspension and additional back, arm and leg rest types. The subject device is a rigid or "non-folding" type power wheelchair base with centre-wheel drive capability, two casters in the rear and two casters in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.

The Invacare® Tracer Manual Wheelchair, Invacare® Tracer® SX5 Manual Wheelchair, Invacare Tracer SX5 Recliner Manual Wheelchair, and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair are intended to provide mobility to persons limited to a sitting position.

The Invacare® Tracer® SX5 Manual Wheelchair is intended to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. The Invacare® Tracer® SX5 Recliner Manual Wheelchair is a Tracer SX5 model with the addition of a recline feature. This recliner model incorporates a mechanism that allows the backrest to recline in angles from 90° to 180°. Both models of the chair have a weight capacity of 250 to 300 lbs. depending on the seat width. Both models also come with an anti-tipper device to ensure the chair remains stable while in use. The Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair has the same intended use as the Invacare® Tracer® SX5 Manual Wheelchair. However, the Tracer IV does not come with a recliner model and has a higher weight capacity of 350 lbs. depending on the configuration. Both models of Tracer IV chairs come with a push-to-lock or pull-to-lock feature to engage and disengage the wheel locks. Both models also come with anti-tippers that allow clearance of 1.5 to 2 inches.

The device is indicated to provide mobility to persons limited to a sitting position.

The Küschall Champion Manual Wheelchair is a manual or attendant operated wheelchair that is designed to provide mobility to persons limited to a sitting position with a weight capacity of 265 lbs. The subject Küschall Champion Manual Wheelchair is available in a number of seat width, depth and height options. The standard components of the subject device include a complete rear wheels (hand rims and tires), front castors, flip-up footrest, carbon cloth guards, fold down backrest, wheel locks and quick release axles. The seat upholstery has a central Velcro band that is used for fixation. There is no prior submission for the subject device.