Search Results

The device is indicated to provide mobility to persons limited to a sitting position.

The Küschall Champion Manual Wheelchair is a manual or attendant operated wheelchair that is designed to provide mobility to persons limited to a sitting position with a weight capacity of 265 lbs. The subject Küschall Champion Manual Wheelchair is available in a number of seat width, depth and height options. The standard components of the subject device include a complete rear wheels (hand rims and tires), front castors, flip-up footrest, carbon cloth guards, fold down backrest, wheel locks and quick release axles. The seat upholstery has a central Velcro band that is used for fixation. There is no prior submission for the subject device.

This document is a 510(k) summary for the Küschall Champion Manual Wheelchair. It describes the device, its intended use, and its comparison to a predicate device to demonstrate substantial equivalence for regulatory clearance. This is not a study proving a device meets acceptance criteria for an AI/ML enabled device, nor does it contain information about clinical trials, acceptance criteria for performance metrics of software, or AI/ML specific testing.

Therefore, I cannot extract the information requested as the document does not pertain to the performance evaluation or acceptance criteria of an AI/ML enabled medical device. The document is a traditional medical device submission (a manual wheelchair) and does not involve AI or algorithms.

Ask a specific question about this device