← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963471 # SUPER SECURITY RESTRAINT (K963471) _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/K963471 ## 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:** Therapeutic ## Indications for Use The DeRoyal Industries, Inc. Super Security Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby providing postural support or enabling examination or protection of the patient or others. The Super Security Restraint is a protective restraint which can be used with a bed or wheelchair. ## Device Story Protective restraint device; limits patient movement for postural support, examination, or safety. Comprised of cool knit polyester material; vest-style design with optional pelvic holder. Used in clinical settings (beds or wheelchairs); operated by healthcare professionals. Provides physical restriction to prevent patient from leaving bed/wheelchair. Benefits include patient safety and facilitation of medical care. ## Clinical Evidence No clinical data provided; equivalence based on design and material similarity to legally marketed predicate devices. ## Technological Characteristics Materials: Cool knit polyester body, polyester binding/straps. Form factor: Vest with optional pelvic holder. Attachment: Bed or wheelchair. Mechanical restraint principle. ## 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 (unspecified) - DeRoyal Industries, Inc. (unspecified) ## 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. Super Security Restraint 510(k) Summary $K963971$ # 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. Super Security Restraint COMMON/USUAL NAME: Security 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. Super Security Restraint is a protective restraint device that is intended for medical purposes to limit patient movements thereby providing postural support or enabling examination or protection of the patient or others. **Device Design/Materials Used/Physical Properties:** The DeRoyal Super Security Restraint is designed similar to those marketed by other manufacturers. The Super Security Restraint is primarily comprised of cool knit material. ## DEVICE INTENDED USE The DeRoyal Industries, Inc. Super Security Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby providing postural support or enabling examination or protection of the patient or others. The Super Security Restraint is a protective restraint which can be used with a bed or wheelchair. ## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | The body is comprised of Cool Knit (polyester). The binding and straps are made of polyester. | Same | | Style Variations | Vest with Pelvic Holder or Vest Only | Same | | Vehicles for Attachment | Bed or Wheelchair | Same | | Length of use | Doctor must prescribe every 24 hours | Same | | Level of Patient Activity | Mildly Agitated or Disoriented Tendency to Leave Bed or Wheelchair | Same | --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963471](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963471) **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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