(73 days)
The intended use of the Model Seeker II, is to provide mobility to adults in rough terrain, with the ability to place themselves in a sitting position on the Wheelchair and have the capacity to operate a simple hand control.
Model Seeker II, Electric Power Wheel Chair
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a power wheelchair and an "Indications for Use Statement". It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications that would allow me to answer your request.
The text is a regulatory document confirming that the "Model Seeker II, Electric Power Wheelchair" is substantially equivalent to a legally marketed predicate device. It defines the intended use and indications for use of the wheelchair. While regulatory clearance often relies on testing, the details of those tests are not present in this document.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).