(113 days)
The intended use of the Rumba S (HP4) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
Not Found
The provided text is a 510(k) premarket notification approval letter for a powered wheelchair. It confirms that the device, the IMC-Heartway, LLC Model Rumba S (HP4), is substantially equivalent to a legally marketed predicate device.
However, this document does not contain any information about acceptance criteria, device performance, study details (sample sizes, expert qualifications, adjudication methods, ground truth, MRMC studies, or standalone performance), or training set information.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as this information is not present in the provided text.
§ 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).