Search Results

The DeRoyal Industries, Inc. Roll Belt is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient or others. The DeRoyal Industries, Inc. Roll Belt is intended to be used with a bed.

The DeRoyal Industries, Inc. Roll Belt is a protective restraint device that is intended for medical purposes to limit patient movements so that the patient remains in the bed while allowing the patient to move from side to side thereby enabling examination or protection of the patient or others.

Device Design/Materials Used/Physical Properties: The DeRoyal Roll Belt is designed similar to those marketed by other manufacturers. The Roll Belt is primarily comprised of nylon or polyester seat belt webbing and cotton flannel.

The provided text is a 510(k) summary for the DeRoyal Industries, Inc. Roll Belt, a protective restraint device. It describes the device, its intended use, and compares its characteristics to other similar devices.

*However, this document does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or any details related to AI/ML performance or MRMC studies.

Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than a detailed performance study with defined acceptance criteria.

Ask a specific question about this device