(67 days)
The intended use of the IMC-Heartway HP-3 HD wheelchair is to provide mobility to adults, limited to a sitting position and have the capability to operate a simple hand control.
Model HP-3 HD Electric Wheelchair
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an electric wheelchair. It does not contain information about the acceptance criteria or a study that proves a device meets those criteria, as it pertains to AI/ML or diagnostic devices.
The document is a regulatory approval for a physical medical device (a powered wheelchair) and focuses on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results in the context you've described.
Therefore, I cannot extract the requested information from 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).