← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963472 # PEDIATRIC VEST RESTRAINT (K963472) _Deroyal Industries, Inc. · FMQ · Nov 14, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963472 ## Device Facts - **Applicant:** Deroyal Industries, Inc. - **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md) - **Decision Date:** Nov 14, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for 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. ## Device Story Protective restraint device for pediatric patients; limits movement to facilitate examination or ensure safety of patient/others. Available as vest restraint or immobilization shirt (using wooden staves to prevent elbow bending). Used in clinical settings (cribs/beds); operated by healthcare professionals. Device secures patient via flannel/knit vest with polyester straps, fastened by hook-and-loop or steel nickel-plated buckles. Benefits include controlled patient positioning during medical procedures or to prevent self-injury. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Materials: cotton flannel, polyester cool knit, polyester twill tape, white webbing. Fasteners: nylon hook and loop, steel nickel-plated buckles. Immobilization shirt staves: wooden tongue depressors. Form factor: vest/shirt in infant and child sizes (2-4, 4-6, 6-8). ## Regulatory Identification A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others. ## Predicate Devices - J.T. Posey Company (not specified) - DeRoyal Industries, Inc. (not specified) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 | --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963472](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963472) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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