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The device is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The EQ10D scooter consists of an un-foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, two lead acid batteries with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set.

The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.

This scooter is designed for use on firm, even surfaces such as concrete, asphalt and indoor flooring.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification for a motorized three-wheeled vehicle (scooter) and primarily focuses on establishing substantial equivalence to a predicate device.

It details:

• The FDA's decision regarding the 510(k) submission.
• Indications for use of the KYMCO EQ10D Scooter.
• A 510(k) summary, including device description, non-clinical testing performed (compliance with various ISO standards), and a statement of substantial equivalence.
• A detailed table comparing the KYMCO EQ10D Scooter to its predicate device (KYMCO EQ 20C, K130940) across numerous specifications and features to demonstrate substantial equivalence.

While non-clinical testing for compliance with ISO standards is mentioned (e.g., ISO 7176-1 to -16, -25, ISO 10993-1, -5, -10, ISO 14971), specific acceptance criteria values for a device's performance (like sensitivity, specificity, accuracy, etc.) and a study showing the device meets those specific numerical criteria are not described. The document focuses on showing the new device is "substantially equivalent" to an already marketed device, meaning it performs similarly and raises no new questions of safety or effectiveness, rather than demonstrating performance against a set of predefined acceptance criteria through a specific study with statistical outcomes.

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