← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963478 # SLEEVED/SLEEVELESS VEST RESTRAINT (K963478) _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/K963478 ## 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 ## Indications for Use The DeRoyal Industries, Inc. Sleeved/ Sleeveless Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Sleeved/ Sleeveless Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair. ## Device Story Protective restraint device; limits patient movement to facilitate examination or ensure safety of patient/others. Used in clinical settings (beds/wheelchairs). Operated by healthcare professionals. Design consists of vest (sleeved/sleeveless) secured via straps to bed or wheelchair. Fastened using nylon hook/loop or steel nickel-plated buckles. Benefits include prevention of patient injury or interference with medical care. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Materials: tietex, cotton flannel, polyester cool knit, polyester twill tape, white webbing. Fasteners: nylon hook and loop or steel nickel-plated buckles. Sizes: XS to XXXL. Attachment: bed or wheelchair. Non-powered, mechanical device. ## 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 - DeRoyal Industries, Inc. ## 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 K963478 DeRoyal Industries, Inc. Sleeved/ Sleeveless Vest Restraint 510(k) Summary 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. Sleeved/ Sleeveless Vest Restraint COMMON/USUAL NAME: Sleeved/ Sleeveless 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. Sleeved/ Sleeveless Vest Restraint is a protective restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others. Device Design/Materials Used/Physical Properties: The DeRoyal Sleeved/ Sleeveless Vest Restraint is designed similar to those marketed by other manufacturers. The Sleeved/ Sleeveless Restraint is primarily comprised of cool knit, cotton, or 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. Sleeved/ Sleeveless Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Sleeved/ Sleeveless Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair. TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | Primarily comprised of tietex, 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. | Same | | Size | X-Small, Small, Medium, Large, X-Large, XX-Large, XXX-Large | Same | | Vehicles for Attachment | Bed or Wheelchair | Same | | Length of use | Doctor must prescribe every 24 hours | Same | | Level of Patient Activity | Mildly to moderately agitated or disoriented | Same | --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963478](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963478) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com