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The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.

The Sunrise device is a cloud-based software device that analyzes data from a sensor (Sunrise sensor 1 or Sunrise sensor 2) placed on the patient's chin. The device detects respiratory events, identifies sleep stages and position. The device generates sleep parameters, e.g. apnea hypopnea index "Sunrise AHI", and position discrete states. Data collected by the device is integrated in a report for further interpretation by the healthcare provider.

The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.

The Empulse R90 is an auxiliary power module to provide augmented power to manual wheelchair users. The device utilizes a single electric drive wheel to provide the augmented power. The device mounts to a camber tube (rigid wheelchair) or a compressible axle (folding wheelchair) to provide the assisted power. On-board sensors, including an inclinometer, accelerometer and motor current sensing to determine when the user wishes to move forward and if the system is on an incline or decline. The removable Lithium lon battery pack is easily switched out to an alternate battery pack if additional range is required. The battery can also be removed if the user wishes to reduce the overall weight. The actuator is used to automatically engage and disengage the locking latch as well as compress the pre-load traction spring when the user wishes to disconnect the EMPULSE R90 from the wheelchair. In the extended position, the actuator allows the pre-load spring to provide sufficient pre-load to the drive wheel to ensure sufficient traction.

The Sunrise SDDA device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.

The Sunrise SDDA device consists of a Sunrise sensor and a cloud-based software device that analyzes data from the sensor when placed on the patient's mandible. The device also includes a mobile application to record patient's responses to questions about their sleep quality and transfer sensor data to the cloud. By analyzing patient's mandibular movements, the device also detects obstructive respiratory disturbances, identifies sleep states, notifies about the Obstructive Sleep Apnea (OSA) severity in a categorical format (non-OSA, mild-OSA, moderate-OSA, severe-OSA), generates sleep structure information (namely, total sleep time, sleep onset latency, wake after sleep onset, sleep efficiency, arousal index) and head position discrete states. Data collected by the device is integrated in a report for further interpretation and diagnosis by the healthcare provider.

The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.

This submission covers the Q700-UP M which includes the following new components to the Sunrise Medical Quickie® Pulse 6SC: - 1. Requires a knee block that was a previous option - 2. Adds a stand-up actuator (PG Drives Technology) to power the stand-up feature - 3. Requires a different version of the power center leg-rest to support the patient's weight when standing. - 4. Adds a CSXM power seating control module (PG Drives Technology) to control the seating during standing - 5. A caster / suspension lock-out system to stabilize the base when stand-up is actuated. The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature. The Sunrise Medical Quickie® Q700-UP M power wheelchairs provide seating and standing function for patients who cannot stand on their own.

Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie power wheelchairs are specifically for people who are slightly smaller in stature—including children.

Quickie and Zippie wheelchairs are battery-powered, user-controlled, electric wheelchairs. All models of these wheelchairs will be offered with an optional wireless pointer control feature. This option entails adding a Bluetooth Mouse Module (BMM)—a small Bluetooth transmitter—mounted to the chair and wired into its control bus. With BMM in place, the wheelchair's controller can then use the pointer-control feature built into the BMM hardware and software. Pointer control can only be activated when the wheelchair is stationary and not actively performing wheelchair functions. The BMM lets users use the chair's joystick, or other input device, to control the pointer functions of Bluetooth-enabled devices (such as personal or tablet computers) while the chair is not in operation. The wireless pointer control feature will be offered on all models of the Quickie Pulse and Zippie ZM-310 series chairs. Technologically, all of these chair designs are identical. Model designations relate to widths and heights of their seats and various components: such as seating, wheels, and other options available. Quickie Pulse chairs are sized to fit medium to large size individuals Zippie ZM-310 chairs fit individuals of smaller stature—including children. These chairs, along with the BMM, are meant for use in healthcare facilities, in the home, outdoors, and other places of individual activity for the disabled.

Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie® power wheelchairs are specifically for people who are slightly smaller in stature-including children.

The Quickie® and Zippie® power wheelchairs are designed for indoor use at care facilities and private residences. The pediatric variant of the Quickie® Pulse 6, branded the Zippie® ZM-310, is intended to provide a slightly broader range of seating size options for people that are smaller in stature-including children. It varies from the Quickie® Pulse 6 only in having smaller seat options. The Quickie® and Zippie® power wheelchairs are center-wheel-drive battery-powered wheelchairs which will perform optimally on firm even surfaces such as concrete, asphalt and indoor flooring. The wheelchairs have steel and aluminum frame structure which is welded and utilizes standard foams and covers for the seat. The braking system can be initiated by either automatic or electric means. The brakes are automatically on except when the wheelchair is turned on and the joystick has been moved away from the neutral position. When the joystick is released or moved back to neutral, the brakes engage again. If the electrical brake system fails, the brakes will default to the closed, or "brakes on" position, thereby stopping the wheelchair. Actuators allow the seating to be adjusted to suit the user and activity. A control system (i.e. controller and joystick) controls motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who has the ability to drive a power wheelchair without having to utilize the services of an attendant. In addition, the controls give the optional capability for attendant control. The optional drive controller R-net system provides further features. The controller is fully programmable.

Breezy Elegance Folding Manual Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.

The product offering consists of a standard folding aluminum wheelchair. (Standard in the sense that it is not built to a specific order, rather it will be built to inventory.) The wheelchairs are - User-propelled, as such, chair has 24" wheels with attached handrims - Foldable (using a cross-brace design) for easier transport and stowage The device comprises - Cross-braced folding frame - Quick-release Axle - Large rear wheels with handrims for self-propulsion - Smaller front wheels on casters for stability - Padded seat sling material designed to support a seat cushion and to fold when the wheelchair frame is folded - An upholstered backrest designed to fold when the wheelchair frame is folded, pre-set angle to 8 - Push handles at top of backrest to allow attendant to aid mobility of rider - Swing-away armrests and swing-in/swing-out legrests (with footplates) Available Options Elevating legrest Anti-tip Tubes

The Sunrise Medical Zippie and Quickie Series Wheelchairs are intended to provide mobility to persons limited to a sitting position.

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The DeVilbiss IntelliPAP/SleepCube Model DV56 ST Series Bilevel is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The Device is to be used in home and clinical environments.

The role of the product from a patient's point of view is to provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea. Positive airway pressure is applied to the oropharynx to act as a pneumatic splint to prevent the collapse of the pharyngeal muscle, which occludes the patient airway during sleep. Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult. The DeVilbiss Bilevel ST product will replace the 9055D in the sleep product line as well as provide a new product offering where time backup rate is necessary. The product will have a reduced manufactured cost, primarily derived from reduced material costs and improved engineering design associated with the existing IntelliPAP/SleepCube product platform. The market has dictated a need for lower cost and smaller sized bilevel units as well as improved functionality such as timed backup rate and manually adjustable inhale/exhale triggering sensitivity. The triggering sensitivity overall must be increased as much as possible to be competitive with other bilevel ST devices currently available. Automatic and manual inhale/exhale trigger sensitivity is to be provided to allow the clinician to customize trigger parameters for specific operating conditions. The DeVilbiss IntelliPAP/SleepCube Bilevel ST product is not intended to meet the needs for the "ventilator" market, which necessitates features such as alarms, higher operating pressures and other ventilator specific functions

The DeVilbiss IntelliPAP/SleepCube Model DV55 S Series is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The Device is to be used in home and clinical environments.

The role of the product from a patient's point of view is to provide a continuous source of bilevel positive airway pressure for the treatment of sleep apnea. Positive airway pressure is applied to the oropharynx to act as a pneumatic splint to prevent the collapse of the pharyngeal muscle, which occludes the patient airway during sleep. Bilevel units are used over conventional CPAP units due to high pressures and/or patient intolerance to continuous pressure, making exhalation difficult. The DeVilbiss Bilevel S product will replace the 9055D in the sleep product line as well as provide a new product offering. The product will have a reduced manufactured cost, primarily derived from reduced material costs and improved engineering design associated with the existing Intellipan/SleepCube product platform. The market has dictated a need for lower cost and smaller sized bilevel units as well as improved functionality such as manually adjustable inhale/exhale triggering sensitivity. The triggering sensitivity overall must be increased as much as possible to be competitive with other bilevel devices currently available. Automatic and manual inhale/exhale trigger sensitivity is to be provided to allow the clinician to customize trigger parameters for specific operating conditions. The DeVilbiss Intellipap/SleepCube Bilevel S product is not intended to meet the needs for the "ventilator" market, which necessitates features such as alarms, higher operating pressures and other ventilator specific functions