Search Results

The Power Standing Dani stand-up wheelchair is a sit to stand mobility device equipped with power driven rear mounted wheels intended for the pediatric population with disabilities which limits their ability to ambulate without assistance. The product is designed for indoor/outdoor use on normal pedestrian terrain such as asphalt, grass, and gravel and not indicated for slopes exceeding 6° in a downhill, uphill or lateral orientation. The device is not intended for use while being transported in a moving vehicle.

The Power Standing Dani stand-up wheelchair (wheelstand) is a sit to stand mobility device equipped a removable prone board and standing platform with a joystick controlled power driven rear mounted wheels, providing the pediatric population with disabilities the providing the pocking to independently ambulate in the standing position. Types of disability diagnosis include spina bifida, cerebral palsy, muscular dystrophy, spinal muscular atrophy, spinal cord injury, and various other neurological disorders.

The Power Standing Dani stand-up wheelchair (wheelstand) is equipped with a vertical positioning prone board with an attached standing platform, inclined slightly forward, to which the pediatric is supported with lateral, anterior and posterior components in the upright position. The prone board and standing platform are comprised of positioning components that are interchangeable and whose location can be adjusted to accommodate the precise needs for each individual. The prone board and attached standing platform are securely mounted to an adjustable steel base frame, to which the power driven rear wheels and front suspension caster wheels are mounted.

The drive power is provided through a rear mounted wheel system, branded as the e-fix® is supplied by Ulrich Alber. Gmbh. Each of the two drive wheels contains a 110 Watt motor, brake and gear box in its hub. The wheels sizes are available in 12" or 24" diameter. The wheel motors are powered with 2x12V (12Ah or 17Ah) batteries, which are secured in a solid mounting rack. Front suspension castor wheels support the front of the frame and allow indirect steering by applying differential power to the rear drive wheels through the joystick controller.

The provided text describes a 510(k) submission for a power stand-up wheelchair called "Power Standing Dani." However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on:

• Device identification: Proprietary name, classification, and predicate devices.
• Intended Use: Description of the target population (pediatric with disabilities limiting ambulation), use environment (indoor/outdoor, normal pedestrian terrain, not for slopes exceeding 6° or transport in moving vehicles), and the device's function as a sit-to-stand mobility aid.
• Device Description: Details on its components, power system (e-fix® add-on), and battery.
• Safety and Effectiveness claims: Based on prior experience with the Manual Standing Dani and the incorporation of an FDA-cleared power add-on. It states that the power add-on provides the same psychological and physiological benefits to those unable to manually self-propel.
• FDA Communication: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices, outlining regulatory requirements, but not discussing specific performance tests or acceptance criteria.

Therefore, I cannot provide the requested table and study details because the information is not present in the provided text.

To answer your request, the original 510(k) submission or a related document outlining the specific performance testing and results would be needed.

Ask a specific question about this device