(352 days)
The Kudu is a wheelchair intended purposes to provide mobility to children limited to a sitting position. It is designed for indoor and outdoor use over smooth surfaces.
Not Found
I'm sorry, but the provided text from the FDA 510(k) letter for the "Kudu" mechanical wheelchair does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document is a substantial equivalence determination letter. It indicates that the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation number, regulation name, regulatory class, and product code. It also includes the "Indications for Use" for the Kudu wheelchair, stating it's "intended purposes to provide mobility to children limited to a sitting position. It is designed for indoor and outdoor use over smooth surfaces."
However, there is no information in this document regarding:
- Acceptance criteria table or reported device performance.
- Study details (sample size, data provenance, ground truth establishment, expert involvement, adjudication, MRMC studies, standalone performance).
- Training set sample size or ground truth.
This type of FDA letter typically confirms substantial equivalence based on comparisons to predicate devices and adherence to general controls, but it does not usually detail the specific performance studies and acceptance criteria in the way you are asking for. That information would typically be found in the 510(k) summary or the full 510(k) submission, which is not provided here.
§ 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).