← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K962964 # HEELBO JOHNNY GRAIT BELT SECURITY BELT (K962964) _Hollister, Inc. · FMQ · Oct 24, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K962964 ## Device Facts - **Applicant:** Hollister, Inc. - **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md) - **Decision Date:** Oct 24, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney. ## Device Story Security belt for patient restraint; cotton construction with polypropylene quick-release buckle and D-ring Velcro loop fasteners. Dimensions: 2 inches wide, 60 inches long. Used in clinical settings (hospitals, nursing homes) to secure patients to wheelchairs, geri-chairs, commodes, beds, or gurneys. Operated by healthcare staff to prevent patient falls or unauthorized movement. Provides physical restraint to enhance patient safety. ## Clinical Evidence No clinical data. Biocompatibility assessment based on history of safe use of materials in the clothing and garment industry and absence of reported skin irritation. ## Technological Characteristics Materials: cotton belt, polypropylene quick-release snap buckle, D-ring Velcro loop fasteners. Dimensions: 2 inches wide by 60 inches long. Mechanical restraint device; no energy source, software, or electronic components. ## 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 - Heelbo Johnny Grait Belt Security Belt ([K962964](/device/K962964.md)) ## 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} Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651 312/489-7711 Telex RCA 297-248 800/323-5444 Fax 312/489-7744 K962964 OCT 24 1996 Heelbo, Inc. Johnny Grait Belt Security Belt ## 510(k) Summary ### 1. Submitter's name, Address and Contact Person | Submitter | Contact Person | | --- | --- | | Heelbo, Inc. 1134 N. Homan Chicago, IL | 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 - October 22, 1996 ### 2. Name of Device: Heelbo Johnny Grait Belt Security Belt ### 3. Name of Predicate Device(s) Heelbo Johnny Grait Belt Security Belt ### 4. Description of Device The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chairs, chair commodes, wheelchairs, beds and gurneys. The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney. ### 5. Statement of Intended Use The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney. {1} Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651 312/489-7711 Telex RCA 297-248 800/323-5444 Fax 312/489-7744 Heelbo, Inc. Johnny Grait Belt Security Belt 6. Statement of Technological Characteristics of the Device The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chairs, chair commodes, wheelchairs, beds and gurneys. 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 Assessment The subject devices are identical in components materials to the predicate devices. The suppliers of the materials used in the fabrication of these devices have stated that there is a history of safe use of their materials in the clothing and garment industry. In addition, Heelbo, Inc., 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 Heelbo Johnny Grait Belt Security Belt is safe and effective for it's intended use and is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K962964](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K962964) **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