← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963060 # HEELBO SECURITY BELT (K963060) _Heelbo, Inc. · FMQ · Nov 4, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963060 ## Device Facts - **Applicant:** Heelbo, Inc. - **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md) - **Decision Date:** Nov 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair. ## Device Story Padded belt (4.75" x 22") with cotton webbed straps; straps tie to wheelchair or geriatric chair frame; used to secure patient in seated position; prevents patient from sliding or falling; operated by caregivers in clinical or home settings. ## Clinical Evidence Bench testing only; no clinical data presented. Biocompatibility assessment based on history of safe use of materials in clothing/garment industry and lack of reported skin irritation. ## Technological Characteristics Padded belt, 4.75 inches wide by 22 inches long; cotton webbed straps; non-powered; mechanical restraint. ## 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 Security Belt ## 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} 11/01/96 12:46 847 918 3860 010/011 Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651 312/489-7711 Telex RCA 297-248 800/323-5444 Fax 312/489-7744 K963060 Heelbo, Inc. Security Belt 510(k) Summary 1. Submitter's name, Address and Contact Person Submitter: Heelbo, Inc. 1134 N. Homan Chicago, IL 60651 Contact Person: 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 - November 1, 1996 2. Name of Device: Heelbo Security Belt 3. Name of Predicate Device(s) Heelbo Security Belt 4. Description of Device The Heelbo Security Belt is a padded belt 4¾ inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated. 5. Statement of Intended Use The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair. 6. Statement of Technological Characteristics of the Device The Heelbo Security Belt is a padded belt 4¾ inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated. 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 {1} 11/01/96 12:47 847 918 3860 011/011 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. Security Belt 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 Security Belt is safe and effective for its intended use and is substantially equivalent to the predicate device. Page 19 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963060](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963060) **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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