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The A-200 is a rear wheel drive powered wheelchair with caster front wheels for indoor use (primarily) but can be used outdoors as well. These wheclchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user opcrating the Penny and Giles (P&G) VSI Electric Wheelchair Control System that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheels.

• Provide mobility to persons physically challenged and limited to sitting positions. .

The A-200 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK Health Carc. The A-200 has a closed "U" frame, controlled by a P&G Controller, electronic regenerative disc brakes and Micro Motor.

This submission does not contain information on acceptance criteria and a study proving that the device meets those criteria. Instead, it is a 510(k) summary for the Otto Bock A-200 Powered Wheelchair, focusing on demonstrating substantial equivalence to a legally marketed predicate device (K000739).

The document states that "The A-200 was tested by TÜV Product Service to the following standards: EN 12184, ISO 7176 - Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC with the conclusion that ‘the test sample fulfills the requirements.’" However, it does not explicitly outline the acceptance criteria within these standards or detail the specific results that demonstrate compliance.

Therefore, I cannot provide the requested table or describe a study proving the device meets specific acceptance criteria based on the provided text. The document primarily focuses on regulatory clearance through substantial equivalence, citing adherence to recognized standards as evidence of safety and effectiveness, rather than presenting a detailed performance study with explicit acceptance criteria and results.

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