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The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor and outdoor mobility to persons restricted to a sitting position. The device allows for the option to climb stairs. The operator(s), either the wheelchair occupant or an assistant, must meet the requirements of the training certification program. The wheelchair occupant must meet the requirements of the user assessment.

The proposed device is an update to the previously cleared iBOT® PMD (K210920). The device retains all the following from the original device including: The device is a multi-mode powered wheelchair that enables users to manewer in confined spaces, climb curbs, stairs, and other obstacles. The device is intended to provide indoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair. The device still includes active stabilization in multiple driving modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height offers benefits in activities of daily living (e.g., accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving. The device still utilizes the primary components of a stair climbing drive wheels, frame, sealed electronics, sensors, battery packs, motors, active stability system and battery charger. It can also be produced without the stair climbing function. The device still allows occupied transportation while an individual is seated in through both a 4-point tie down system and a docking system. In addition, the device incorporates the following updates to the iBOT® PMD design: - · Modified the device to add the Motion Concepts Modular Power Positioning Seating System (K150574) as an option / accessory which includes greater degrees of posterior tilt, power recline with shear reduction, and power elevating legrests - · Adds anterior tilt to the power positioning options available on the product - · Adds the existing power seat elevation to the Standard Mode of the device - · Updates that operator of the chair can be the occupant or an attendant to increase clarity - · Updates contraindications to increase clarity - · Adds optional seat interface brackets that include seat height and static tilt angle adjustments - · Minor redesign of front casters and changes of materials / processes in support of design for manufacturing efforts - · Software revisions / changes - · Removes the contraindication for a mechanical ventilator mount can be added to the device, when the device is modified to remove stair and balance modes.

The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program. The device allows for the option to climb stairs. Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program. The iBOT® Personal Mobility Device ("iBOT® PMD") Occupied Transport option is indicated for providing persons, unable to transfer from their wheelchair into a standard factory motor vehicle seat, the option for transportation while seated in their iBOT® PMD wheelchair.

The proposed device is an update to the previously cleared device Next Generation iBOT® (K172601). The device retains all the following from the original device including: The device is a multi-mode powered wheelchair that enables users to manewer in confined spaces, climb curbs, stairs, and other obstacles. The device is intended to provide indoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair. The device still includes active stabilization in modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height offers benefits in activities of daily living (e.g. accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving. The proposed device still utilizes the primary components of a stair climbing power wheels, frame, sealed electronics, sensors, battery packs, motors, seative stability system and battery charger. It can also be produced without the stair climbing function. In addition, the device will incorporate the following updates to the Next Generation iBOT® design: - Allows for occupied transportation in a motor vehicle ● - Incorporates the use of an alternate seating system, mounting and peripherals ● - . Wheel gear train changed from spur to helical - Redesigned brake release lever mechanism - Changes of materials / processes in support of Design for Manufacturing efforts . - Software revisions / changes ● - Incorporates change of the Trade name to iBOT® PMD ● - Updates contraindications to increase clarity ●