(21 days)
The BRIX wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.
BRIX wheelchair
The provided text is a 510(k) Premarket Notification from the FDA to Meyra, Inc. regarding their BRIX mechanical wheelchair.
This document is a regulatory clearance notice, confirming that the FDA has found the BRIX wheelchair to be substantially equivalent to legally marketed predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as typically found in a study report for a medical device.
Therefore, I cannot fulfill your request for the detailed information you've asked for, as it is not present in the provided text. This document is a legal and regulatory clearance for market entry, not a technical study report.
If you have a different document that details the performance study for the BRIX wheelchair, I would be happy to analyze it for the information you've requested.
§ 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).