← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963371 # BEST STRAP RESTRAINT (K963371) _Morrison Medical Products · FMQ · Nov 7, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963371 ## Device Facts - **Applicant:** Morrison Medical Products - **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md) - **Decision Date:** Nov 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient’s body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. ## Device Story Restraint system consisting of five nylon straps with hook-and-loop fasteners; secures patient to backboard or stretcher frame at shoulder, chest, pelvis, thighs, and ankles. Straps are color-coded for application assistance; threaded around backboard/stretcher frame; secured via hook-and-loop for rapid application and release. Used in emergency medical services or clinical settings to stabilize patients during transport. Benefits include patient immobilization and safety during movement. ## Clinical Evidence No clinical data. Biocompatibility review of materials indicated low potential for adverse skin reaction; no reports of skin irritation noted. ## Technological Characteristics System comprised of five nylon straps with hook-and-loop fasteners. Color-coded for application. Mechanical restraint system; no energy source or software. ## 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 - Best Strap Restraint (k963371) ## 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} MORRISON MEDICAL PRODUCTS NOV - 7 1996 k963371 # Morrison Medical Products ## Best Strap Restraint # Safety and Effectiveness Summary ## 1. Submitter's name, Address and Contact Person | Submitter | Contact Person | | --- | --- | | Morrison Medical Products 610 W. Town Street Columbus, OH 43215-4446 | Joseph S. Tokarz; Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Ph: (847)680-2849, Fax: (847)918-3860 | Date Summary Prepared - August 23, 1996 ## 2. Name of Device: Best Strap Restraint ## 3. Name of Predicate Device(s) Best Strap Restraint ## 4. Description of Device The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient’s body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher frame and secured with the Hook and Loop to allow for quick and easy application and release. ## 5. Statement of Intended Use The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient’s body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. ## 6. Statement of Technological Characteristics of the Device The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient’s body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher 610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400 {1} MORRISON MEDICAL PRODUCTS # Morrison Medical Products ## Best Strap Restraint frame and secured with the Hook and Loop to allow for quick and easy application and release. The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency’s labeling requirements set forth in the draft “Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints” dated December 1995. ## 7. Biocompatibility The subject devices are identical in component materials to the predicate devices. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction. ## 8. Conclusion Based upon the information presented above it is concluded that the proposed Morrison Medical Best Strap Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device. Page 19 610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963371](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963371) **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