Infant whole-body immobilizer, reusable
13 devices GMDN 45127
An infant whole-body immobilizer is a reusable device designed to temporarily restrict an infant's movement during medical procedures. It creates a strait-jacket effect to keep the infant still for therapeutic or diagnostic interventions, using a combination of flexible materials like fabric or plastic, and may include rigid elements such as a board for added support.
As a reusable device, it is intended for multiple uses after appropriate cleaning and reprocessing according to manufacturer instructions. Devices in this category are subject to general regulatory controls applicable to medical devices, with specific requirements varying by jurisdiction based on risk assessment and intended use.