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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

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The provided text is a 510(k) premarket notification letter for a medical device: "J.D. 3-Wheeled Scooter, ES-350 Citybug II/Rabbit". This document is a regulatory approval letter from the FDA and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. Substantial equivalence for this type of device typically relies on demonstrating that the new device has the same intended use and technological characteristics as an already approved device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This process usually involves comparison of specifications, performance data (like speed, range, stability, braking), and safety features to the predicate device, rather than a clinical study with detailed acceptance criteria as one might expect for a diagnostic or therapeutic device.

Therefore, I cannot provide the requested information based on the given text.

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