Search Results

the temp permanently mobility impaired individual to move about in doors, and out through the use of a battery powere wheeled device. Weight capacity individual not to exceed 250 l

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA, and it does not contain any information regarding device acceptance criteria, study data, or performance metrics. It simply states that the devices (Independence 624 and Independence 324) are substantially equivalent to previously marketed devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided document.

Ask a specific question about this device

THE INDEPENDENCE 324 IS INTENDED TO AID IN THE TEMPORARY OR PERMANENTLY MOBILITY IMPAIRED INDIVIDUAL TO MOVE ABOUT INDOORS, AND OUTDOORS, THROUGH THE USE OF A BATTERY POWERED, MOTORIZED THREE-WHEELED VEHICLE. THE WEIGHT CAPACITY OF THE INDIVIDUAL IS NOT TO EXCEED 300 LBS.

Not Found

This is an FDA premarket notification (510(k)) letter for the "INDEPENDENCE 324" and "INDEPENDENCE 624" devices. This document does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory clearance letter indicating that the FDA has found the devices substantially equivalent to previously marketed devices.

Therefore, I cannot provide the requested information based on this document.

Ask a specific question about this device