← Product Code [FMQ](/productcode/FMQ) · K962778 # THE L-BOW ARM RESTRAINT (K962778) _Heelbo, Inc. · FMQ · Oct 9, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K962778 ## Device Facts - **Applicant:** Heelbo, Inc. - **Product Code:** [FMQ](/productcode/FMQ.md) - **Decision Date:** Oct 9, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital - **Attributes:** Therapeutic, Pediatric ## Indications for Use The L-Bow Arm Restraint fits over the patient’s elbow and is intended to limit the patient’s movement, particularly away from their face and IV tubing, by keeping their arm in an extended position. ## Device Story L-Bow Arm Restraint is a physical restraint device; consists of flexible plastic insert covered in soft polyester foam; secured via Velcro fasteners. Wrapped around patient elbow to maintain arm in extended position; limits range of motion. Used in clinical settings to prevent patient interference with IV tubing or facial access. Device is machine washable; available in five sizes (infant, toddler, youth, adult medium, adult large). ## Clinical Evidence No clinical data. Biocompatibility assessment based on history of safe use of materials in clothing/garment industry and absence of reported skin irritation. ## Technological Characteristics Flexible plastic insert; polyester foam fabric cover; Velcro fasteners. Available in five sizes ranging from 7"x5" to 12"x13". 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 - L-Bow Arm Restraint ([K962778](/device/K962778.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 K962778 OCT - 9 1996 Heelbo, Inc. The L-Bow Arm Restraint # Safety and Effectiveness Summary ## 1. Submitter's name, Address and Contact Person **Submitter** Heelbo, Inc. 1134 N. Homan Ave. 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 - July 15, 1996 ## 2. Name of Device: L-Bow Arm Restraint ## 3. Name of Predicate Device(s) - L-Bow Arm Restraint ## 4. Description of Device The L-Bow Arm Restraint is constructed of a flexible plastic insert that is covered with soft polyester foam fabric held securely closed with Velcro® fasteners. The L-bow Arm Restraint is wrapped around the patient’s elbow and is intended to limit the patient’s movement, particularly away from their face and IV tubing, by keeping their arm in an extended position. The Velcro® fasteners are easy to use and offer a secure firm hold. The L-Bow may be machine washed. The L-Bow is available in three sizes to accommodate various infant, toddler and youth sizes and two sizes to accommodate adults. The following are the sizes available: | Pediatric | | | Adult | | | | --- | --- | --- | --- | --- | --- | | Size | Dimensions (inches) | Stock No. | Size | Dimensions (inches) | Stock No. | | Infant | 7" x 5" | 9380 | Medium | 10" x 11" | 9395 | | Toddler | 8" x 6" | 9385 | Large | 12" x 13" | 9398 | | Youth | 10" x 8.5" | 9390 | | | | {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. The L-Bow Arm Restraint ## 5. Statement of Intended Use The L-Bow Arm Restraint fits over the patient’s elbow and is intended to limit the patient’s movement, particularly away from their face and IV tubing, by keeping their arm in an extended position. ## 6. Statement of Technological Characteristics of the Device The L-Bow Arm Restraint is constructed of a flexible plastic insert that is covered with soft polyester foam fabric held securely closed with Velcro® fasteners. The L-bow Arm Restraint is wrapped around the patient’s elbow and is intended to limit the patient’s movement, particularly away from their face and IV tubing, by keeping their arm in an extended position. The Velcro® fasteners are easy to use and offer a secure firm hold. 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 Assessment 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 L-Bow Arm Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device. Page 19 --- **Source:** [https://fda-staging.innolitics.com/device/K962778](https://fda-staging.innolitics.com/device/K962778) **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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