PEDIATRIC VEST RESTRAINT

{0} NOV 14 1996 DeRoyal Industries, Inc. Pediatric Vest Restraint 510(k) Summary K963472 SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED SUBMITTER INFORMATION NAME: DeRoyal Industries, Inc. ADDRESS: 200 DeBusk Lane Powell, TN 37849 TELEPHONE: (423) 938-7828 CONTACT: Camille Matlock DATE OF PREPARATION: August 30, 1996 DEVICE NAMES NAME: DeRoyal Industries, Inc. Pediatric Vest Restraint COMMON/USUAL NAME: Pediatric Vest Restraint CLASSIFICATION NAME (if known): Restraint, Protective (80FMQ) PREDICATE OR LEGALLY MARKETED DEVICES J.T. Posey Company DeRoyal Industries, Inc. DEVICE DESCRIPTION The DeRoyal Industries, Inc. Pediatric Vest Restraint is a protective restraint device that is intended for medical purposes to limit pediatric patient movements thereby enabling examination or protection of the patient or others. The Pediatric Vest Restraint is also available as an immobilization shirt which prevents the pediatric patient's arms from bending at the elbows with the use wooden staves (tongue depressors). Device Design/Materials Used/Physical Properties: The DeRoyal Pediatric Vest Restraint is designed similar to those marketed by other manufacturers. The Pediatric Vest Restraint is primarily comprised of flannel or cool knit with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles. DEVICE INTENDED USE The DeRoyal Industries, Inc. Pediatric Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient movements thereby enabling examination or protection of the patient or others. The Pediatric Vest Restraint is a protective restraint that can be used with a crib or bed. TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | Primarily comprised of cotton flannel or polyester cool knit. The straps are made of polyester twill tape and white webbing. Fasteners are made of hook and loop or steel nickel plated buckles. The stave for the immobilization shirt is made of wooden tongue depressors. | Same | | Size | Infant, child (2-4)(4-6)(6-8) | Same | | Vehicles for Attachment | Crib or Bed | Same | | Length of use | Doctor must prescribe every 24 hours | Same | | Level of Patient Activity | Vest Restraint: Limb Interference by pediatric patient Immobilization Shirt: Pediatric patient tends to bend elbows | Same |