← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963199 # HEELBO PELVIC RESTRAINT (K963199) _Hollister, Inc. · FMQ · Nov 1, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963199 ## 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:** Nov 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use The Heelbo Pelvic Restraint is intended to help secure a patient while seated in a wheelchair or geriatric chair. ## Device Story Heelbo Pelvic Restraint is a patient restraint device constructed of polyester mesh. It features front and back panels with sewn-on straps to secure a patient to a wheelchair or geriatric chair. The design includes a catheter access slot for patients with indwelling catheters. Available in small, medium, and large sizes. The device is machine washable for reuse. It is used in clinical or long-term care settings to prevent patient falls or unauthorized movement from seating. Healthcare providers or caregivers operate the restraint by securing the straps to the chair. The device provides physical stability for the patient. ## Clinical Evidence No clinical data. Biocompatibility is supported by the history of safe use of component materials in the clothing and garment industry and the absence of reported skin irritation. ## Technological Characteristics Constructed of polyester mesh. Features sewn-on straps for securement and a catheter access slot. Available in three sizes (small, medium, large). Machine washable. ## 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 Pelvic Restraint (K963/99) ## 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} K963/99 Heelbo, Inc. 1134 N. Homan Ave. Telex RCA 297-248 Chicago, IL 60651 800/323-5444 312/489-7711 Fax 312/489-7744 NOV 1 1996 Heelbo, Inc. Pelvic Restraint # Safety and Effectiveness Summary ## 1. Submitter's name, Address and Contact Person | Submitter | Contact Person | | --- | --- | | Heelbo, Inc. | Joseph S. Tokarz; Manager, Regulatory Affairs | | 1134 N. Homan Ave. | Hollister Incorporated | | Chicago, IL 60651 | 2000 Hollister Drive Libertyville, IL 60048 | | | Ph: (847)680-2849, Fax: (847)918-3860 | Date Summary Prepared - August 13, 1996 ## 2. Name of Device: Heelbo Pelvic Restraint ## 3. Name of Predicate Device(s) Heelbo Pelvic Restraint ## 4. Description of Device The Heelbo Pelvic Restraint is constructed of polyester mesh. Straps sewn onto both sides of the front panel and back panel are used to secure the patient to the wheelchair or geriatric chair. A catheter access slot has been incorporated into the restraint design for those patients that utilize an indwelling catheter. The Pelvic Restraints are available in three sizes, small, medium and large to accommodate a wide range of patients. The Pelvic Restraints are machine washable for continued use. ## 5. Statement of Intended Use The Heelbo Pelvic Restraint is intended to help secure a patient while seated in a wheelchair or geriatric chair. ## 6. Statement of Technological Characteristics of the Device The Heelbo Pelvic Restraint is constructed of polyester mesh. Straps sewn onto both sides of the front panel and back panel are used to secure the patient to the wheelchair or geriatric chair. A catheter access slot has been incorporated into the restraint design for those patients that utilize an indwelling catheter. Page 19 {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. Pelvic Restraint The Pelvic Restraints are available in three sizes, small, medium and large to accommodate a wide range of patients. The Pelvic Restraints are machine washable for continued use. 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 [501(k)] Submissions for Protective Restraints” dated December 1995. 7. Biocompatibility The subject devices are identical in component materials to the predicate devices. The suppliers of the materials use 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 Pelvic Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device. Page 20 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963199](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963199) **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