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The device is intended to enhance personal mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users that are able to walk but prefer to ride. Some diseases/conditions that might cause a user to employ this type of device are arthritis, leg or foot injury or impairment, severe back impairment, paralysis, et cetera.

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The provided text is a set of FDA 510(k) clearance letters for three models of motorized three-wheeled vehicles (Companion 221, 321, 421). These documents are regulatory approvals and DO NOT contain information about acceptance criteria, study design, or performance metrics that would typically be found in a clinical study report or a detailed technical submission.

Therefore, I cannot provide the requested information from the given text.

The documents focus on:

• Device Name & Regulation: Identifying the specific device models and their regulatory classification.
• Indications For Use: Defining the intended purpose and user population for the devices.
• Substantial Equivalence: Stating that the devices are substantially equivalent to pre-amendment devices, which is the basis for 510(k) clearance.
• General Controls: Mentioning the regulatory requirements for the device.

To answer your request, information from a different type of document (e.g., a 510(k) summary, a design validation report, or a clinical study report) would be needed.

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