← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963494 # MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP (K963494) _Morrison Medical Products · FMQ · Nov 6, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963494 ## 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 6, 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 Disposable Restraint Strap is intended to help secure a patient’s body while lying on a backboard. ## Device Story Disposable restraint strap; acrylic-coated polyester woven material; adhesive bands on ends. Operation: strap placed across patient body; woven through backboard hand holds; secured by adhering strap to itself. Removal: cut with scissors after use. Used in emergency medical services or clinical settings to secure patients to backboards. Benefit: prevents patient movement during transport. ## Clinical Evidence No clinical data. Biocompatibility based on history of use of identical materials in previously marketed devices with no reported skin irritation. ## Technological Characteristics Acrylic-coated polyester woven material; adhesive-backed ends; manual application; non-electronic; non-sterile; single-use. ## 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 - Morrison Medical Disposable Restraint Strap ## 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 - 6 1996 X963494 # Morrison Medical Products ## Disposable Restraint Strap # 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 29, 1996 ## 2. Name of Device: Morrison Medical Disposable Restraint Strap ## 3. Name of Predicate Device(s) Morrison Medical Disposable Restraint Strap ## 4. Description of Device The Morrison Medical Disposable Restraint Strap is intended to help secure a patient’s body while lying on a backboard. The straps are constructed of an acrylic coated polyester woven material with an adhesive band on each end of the strap. The patient is secured to the backboard by lying the strap across the patient’s body and peeling the release paper from the strap. The strap is woven through the hand hold in the backboard and stuck back onto the polyester strap. After use the strap is cut off with scissors. ## 5. Statement of Intended Use The Morrison Medical Disposable Restraint Strap is intended to help secure a patient’s body while lying on a backboard. ## 6. Statement of Technological Characteristics of the Device 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. Page 18 610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400 {1} MORRISON MEDICAL PRODUCTS # Morrison Medical Products ## Disposable Restraint Strap ## 7. Biocompatibility The materials used to manufacture this device are identical to a similar marketed device under comparable conditions of use. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in this device. ## 8. Conclusion Based upon the information presented above it is concluded that the proposed Morrison Medical Disposable Restraint Strap is safe and effective for its intended use and is substantially equivalent to the predicate device. 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/K963494](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963494) **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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