← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963414 # MULTIPLE BELTS (K963414) _J. T. Posey Co. · FMQ · Nov 22, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963414 ## 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 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use These products are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, geriatric chair, or gurney. ## Device Story Protective restraints; waist/torso support belts; secure patient to bed, geriatric chair, wheelchair, or gurney via straps. Straps secured using knots, double D rings, hook and loop, standard buckles, or quick-release hardware. Used in clinical/long-term care settings to hinder egress or aid positioning. Operated by healthcare staff. Benefit: patient safety through fall prevention and positioning stability. ## Clinical Evidence No clinical data; bench testing only. Devices have been in commercial distribution for up to 20 years. ## Technological Characteristics Waist/torso support belts; strap-based securement system using knots, double D rings, hook and loop, or buckles. Mechanical restraint design; no energy source or software. ## 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. Protective Restraints (legally marketed devices per FDA guidance) ## 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 22 1996 K963444 Custody Posey Company 5635 Peck Road • Arcadia, California 91006-0020 U.S.A. Customer Service Toll Free: (800) 44-POSEY Tel: (818) 443-3143 Fax: (818) 443-5014 # SAFETY AND EFFECTIVENESS SUMMARY 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: K963414 Trade Name: Protective Restraints Common Name: Belts Classification Name: Protective Restraints The devices included in this 510(k) submission support the waist or torso area. The product is closed around the patient by encircling the hips, legs or chest. The product is secured to the bed, geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, double D rings, hook and loop, standard buckles, or quick release buckles or hardware (screws). These products are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, geriatric chair, or gurney. The devices used for comparative purposes are identical to the belts 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) Pre-market 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 belts 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/K963414](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963414) **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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