(45 days)
This wheelchair is designed as a transport base for pediatric and adult clients. This device will not diagnose, treat, prevent, oure or pollarity and autor chems. I hus devi users users.
Not Found
This is a 510k clearance letter for a medical device called "Tri Pod", a mechanical wheelchair. The letter states that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require a new premarket approval (PMA) application.
However, the provided document does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or study methodologies.
Therefore, I cannot answer your specific questions as the relevant data is not present in the provided text. The document is solely an FDA clearance letter and does not include technical specifications or study details.
§ 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).