← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963370 # CINCH STRAP WITH BUCKLE (K963370) _Morrison Medical Products · FMQ · Nov 8, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963370 ## 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 8, 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 Products Cinch Strap with Buckle is intended to limit the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting position. The device is also intended to be used as an assist in securing equipment. ## Device Story Cinch Strap with Buckle; nylon hook and loop material; heat-sealed nylon hook end. Used to limit patient movement or secure equipment. Applied by clinicians in clinical settings. Provides physical restraint or equipment stabilization. Benefits include patient/staff safety and equipment security. ## Clinical Evidence Bench testing only; no clinical data presented. Biocompatibility review of materials indicated low potential for adverse reaction. ## Technological Characteristics Nylon hook and loop material; heat-sealed construction. Available in sizes 1" x 42", 1.5" x 18", and 1.5" x 30". ## 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 - Cinch Strap with Buckle ## 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 K 963370 # Morrison Medical Products ## Cinch Strap with Buckle NOV - 8 1996 # 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: Cinch Strap with Buckle ## 3. Name of Predicate Device(s) Cinch Strap with Buckle ## 4. Description of Device The Morrison Medical Products Cinch Strap with Buckle is intended to limit a patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting position. The device is also intended to be used as an assist in securing equipment. The Cinch Strap with Buckle is constructed of a nylon hook and loop material. Heat Sealed to one end is a nylon hook material that is used to secure the patient or equipment in the Cinch Strap with Buckle. The Cinch Strap with Buckle is available in the following sizes: - Series 1142 - 1" x 42" - Series 1150 - 1½" x 18" - Series 1160 - 1½ x 30" ## 5. Statement of Intended Use The Morrison Medical Products Cinch Strap with Buckle is intended to limit the patient’s movement to the extent necessary for treatment, examination, or protection of the patient Page 18 610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400 {1} MORRISON MEDICAL PRODUCTS # Morrison Medical Products ## Cinch Strap with Buckle or others. The device can be used in the supine or sitting position. The device is also intended to be used as an assist in securing equipment. ## 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. ## 7. Biocompatibility The subject devices are identical in component materials to the predicate devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction. In addition, Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with these materials. ## 8. Conclusion Based upon the information presented above it is concluded that the proposed Morrison Medical Products Cinch Strap with Buckle 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/K963370](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963370) **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