Alternating-pressure bed mattress overlay, single-use

An alternating-pressure bed mattress overlay, single-use is a pad or thin mattress placed on top of a standard bed mattress. It contains parallel air chambers that are alternately inflated and deflated by a forced-air system to shift pressure points on the body, helping to relieve discomfort and prevent pressure ulcers in immobilized or at-risk patients.

As a single-use device, this overlay is intended for one patient and one episode of use before disposal. It is regulated as a medical device based on its intended use and risk profile, with regulatory requirements focused on safety, performance, and sterility where applicable, without reuse or reprocessing.