← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963439 # PEDIATRIC LIMB HOLDERS (K963439) _J. T. Posey Co. · FMQ · Nov 19, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963439 ## Device Facts - **Applicant:** J. T. Posey Co. - **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md) - **Decision Date:** Nov 19, 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 These products are intended to limit limb movement or finger movement in a hospital bed or crib. ## Device Story Pediatric limb holders; designed to limit limb/finger movement; device encircles wrists, hands, or ankles; secured to hospital bed or crib via straps using quick-release knots or safety pins; used in clinical settings; operated by healthcare staff; prevents patient self-injury or interference with medical treatment. ## Clinical Evidence No clinical data; bench testing only based on historical performance and established market presence. ## Technological Characteristics Limb restraint system; fabric/strap construction; mechanical securement via straps and quick-release knots or safety pins; non-powered; manual operation. ## 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 - J.T. Posey Co. pediatric limb holders (legally marketed/exempt status) ## 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} NOV-18-1996 12:38 J. T. Posey Co. 818 443 5064 P.10/11 K963439 Customer Service Toll Free: (800) 44-POSEY Tel: (818) 443-3143 Fax: (818) 443-5014 # PAYROLL # CONSULATE # Posey Company 5635 Peck Road • Arcadia, California 91006-0020 U.S.A. # SAFETY AND EFFECTIVENESS SUMMARY NOV 19 1996 JT Posey Company 5635 Peck Road Arcadia, CA 91006 Michael Keefe General Manager August 30, 1996 Revised: November 18, 1996 Phone # (818) 443-3143 FAX # (818) 443-5014 Reference Number: K963439 Trade Name: Protective Restraints Common Name: Pediatric limb holders Classification Name: Protective Restraints The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the hospital bed or crib via straps. These straps are securely connected to the hospital bed or crib by quick release knots or with the use of a safety pin. These products are intended to limit limb movement or finger movement in a hospital bed or crib. The devices used for comparative purposes are identical to the pediatric limb holders as described in this submission and produced or sold by the J.T. Posey Co. This premarket submission is submitted in response to the agency's final rule published on March 4, 1996 in the Federal Register 21 CFR 880 and 21 CFR 890 Medical Devices, Protective Restraints - Revocation of Exemptions from 510(k) Premarket Notification Procedures and Current Good Manufacturing Practice Regulation. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for comparison: "Predicate device FDA indicated that it would be appropriate for manufacturers to reference their current products as legally marketed devices for comparison purposes in their submissions. It would also be appropriate to reference any approved 510(k)s that manufacturers have submitted for their products." The pediatric limb holders are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission, August 30, 1996. The limb holders have been manufactured and in commercial distribution for up to 20 years. Manufacturers and worldwide distributors of quality healthcare products since 1937 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963439](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963439) **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