(15 days)
The Cat multi-functional active wheelchair manufactured by movingpeople.net is intended for use by person(s) limited to a sitting position. It is designed to increase functionality for the person(s) in The Cat was designed to increase functionality. The most natural postures and movements that people use during the day, have been analyzed, described and resulted in a mechanism that is individually adjusted. This is know as the IPPA. IPPA stands for Intelligent Posture and Purpose Adjustments. It means that you get a mechanism with which you can change your sitting posture in a second into the best desired position.
Cat multi-functional active wheelchair
The provided documents from the FDA do not contain information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details for the "CAT Active Wheelchair."
The documents consist of:
- A 510(k) clearance letter (K020737): This letter confirms that the FDA has found the "CAT Active Wheelchair" to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements but does not delve into specific performance study details.
- Indications for Use statement: This describes the intended use and features of the device, particularly its "Intelligent Posture and Purpose Adjustments (IPPA)" mechanism.
To answer your request, information typically found in a 510(k) summary or an extensive premarket submission would be needed. This type of detail is not present in the provided FDA clearance letter and Indications For Use statement.
§ 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).