← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963387 # DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP (K963387) _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/K963387 ## 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 - **Attributes:** Pediatric ## Indications for Use The Morrison Medical Products Limb Restraint with Double D-Ring and Strap is intended to be a protective limb restraint that limits 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. ## Device Story Protective limb restraint device; limits patient movement for treatment, examination, or safety. Construction: foam/fabric laminate reinforced with polyester webbing strap. Closure mechanisms: double D-ring or hook-and-loop. Available in adult, youth, and infant sizes. Used in clinical settings; applied by healthcare providers. Benefits: prevents patient injury or interference with medical procedures. ## Clinical Evidence No clinical data. Biocompatibility review of materials indicated low potential for adverse skin reaction; no reports of skin irritation noted. ## Technological Characteristics Materials: foam/fabric laminate, polyester webbing. Closure: double D-ring or hook-and-loop. Sizes: adult, youth, infant. Mechanical restraint device; 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 - Limb Restraint with Double D-Ring and Strap - Limb Restraint with 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} K963387 M MORRISON MEDICAL PRODUCTS NOV - 8 1996 # Morrison Medical Products ## Limb Restraint with Double D-Ring and 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 26, 1996 ## 2. Name of Device: Limb Restraint with Double D-Ring and Strap Limb Restraint with Strap ## 3. Name of Predicate Device(s) Limb Restraint with Double D-Ring and Strap Limb Restraint with Strap ## 4. Description of Device Morrison Medical Products has developed two limb restraints that are intended to be a protective restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The following is a description of the two limb restraints. Limb Restraint with Double D-Ring and Strap: The Double D-Ring and Strap limb restraint uses it its construction a foam/fabric laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient’s limb using a double D-ring closure mechanism. The Limb Restraint with Double D-Ring and Strap is available in the following size: Stock No. 1114 Adult Size: Cuff size: 11½" long x 2½" wide Strap: 1" wide x 60" long Page 19 610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400 {1} M MORRISON MEDICAL PRODUCTS # Morrison Medical Products ## Limb Restraint with Double D-Ring and Strap **Limb Restraint with Strap:** The Limb Restraint with Strap is constructed of a foam laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient using a hook and loop closure. The Limb Restraint with Strap is available in the following sizes: | Stock No. 1103 | Adult size | Cuff size: 11½" long x 2½" wide Strap: 1" wide x 60" long | | --- | --- | --- | | Stock No. 1124 | Youth size | Cuff size: 9" long x 2" wide Strap: 1" wide x 36" long | | Stock No. 1119 | Infant size | Cuff size: 6" long x 1¼ wide Strap: 1" wide x 24" long | ## 5. Statement of Intended Use The Morrison Medical Products Limb Restraint with Double D-Ring and Strap is intended to be a protective limb restraint that limits 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. ## 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. 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. Page 20 610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400 {2} MORRISON MEDICAL PRODUCTS # Morrison Medical Products ## Limb Restraint with Double D-Ring and Strap ### 8. Conclusion Based upon the information presented above it is concluded that the proposed Morrison Medical Products Limb Restraint with Double D-Ring and Strap is safe and effective for its intended use and is substantially equivalent to the predicate device. Page 21 610 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/K963387](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963387) **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