(189 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The proposed device, Manual Wheelchair, driven by manual operation of rear tire, or pushed by caretaker. This product is mainly designed to be used to take care of the disabled or elderly, it is driven by manual operation of rear tire, or pushed by caretaker. The Manual Wheelchair consists of Frame, Footplate, Front castor, Rear wheel, Anti-tipper, Armrest, Brake, Central fork. The Manual Wheelchair has four models: JR201, JR202, JR203, JR204.
The provided document is a 510(k) summary for a Manual Wheelchair and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the acceptance criteria or study details as requested for an AI device.
The document discusses the mechanical wheelchair's specifications, non-clinical tests (meeting ISO standards), and a comparison to a predicate device to demonstrate substantial equivalence, but it does not mention any AI components, algorithms, or associated studies.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).