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The intended use of TRAX is to provide indoor and outdoor mobility to persons restricted to a sitting position.

Powered wheelchair, battery-operated device with wheels that is intended for medical purposes to provide indoor and outdoor mobility to persons restricted to a sitting position. Class II. The indoor use is depending of available space.

The Permobil powered wheelchair TRAX is rear wheel driven, battery powered, motor driven and is controlled by the Permobil wheelchair controller SAFEGATE. The user interface is a joystick manufactured by Sakai for proportional control of the speed and the steering.

The wheelchair is powered by two 12V 97 Ah gel batteries.

Theoretical driving range on the fully charged batteries is 30 - 50 km depending of the terrain the chair is driven on.

The wheelchair consists of the following basic sub-sections:

• · Base with two direct-drive units with integrated parking brakes, two 10"x3" rear wheels, suspension with stabilizer and two 12V 97Ah batteries.
• Extendable and pivoted front, length adjustable 0-200 mm (0-8"), teleflex . wire steering, suspension and two 8"x2,5" front wheels.
• SAFEGATE TRAX Power electronics. .
• · Seating system.

The base is of welded steel construction with laser cut sheet details. The direct-drive units consist of two 12V DC permanent magnet motors with gears and integrated parking brakes.

I am sorry, but based on the provided document, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not available.

The document is a 510(k) Summary of Safety and Effectiveness for the Permobil Powered Wheelchair TRAX. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific performance acceptance criteria and a study to prove they are met for the TRAX device itself.

Here's what the document does include:

• Intended Use: "to provide indoor and outdoor mobility to persons restricted to a sitting position."
• Description of the Device: Details on its components (base, drive units, batteries, steering, seating system).
• Substantial Equivalence Claim: States that the TRAX is substantially equivalent to predicate devices (Max90 (K870224) and Exterior (K870225)) with respect to intended use, energy source, and materials.
• Safety and Effectiveness Claim: States that the TRAX has "in substantials the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the design changes declared in this submission do not raise new questions of safety and effectiveness."

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document's purpose is to argue for substantial equivalence to already approved devices, implicitly relying on the predicate devices having met necessary performance and safety criteria. It does not detail specific acceptance criteria for the TRAX and then a study showing how the TRAX met those specific criteria.

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