← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963410 # POSEY STRAIGHT JACKETS (K963410) _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/K963410 ## 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 - **Attributes:** Therapeutic ## Indications for Use These products are intended to limit movement in a hospital patient. ## Device Story Straight jackets; physical restraints; limit patient movement. Input: patient limbs (wrists, hands, ankles). Mechanism: fabric enclosure secured by straps with heavy-duty corset or standard buckles. Output: physical restriction of movement. Used in hospital settings; operated by clinical staff. Benefit: prevents patient self-injury or interference with medical treatment. ## Clinical Evidence No clinical data; bench testing only. Device relies on historical safety and effectiveness data from up to 20 years of commercial distribution. ## Technological Characteristics Fabric-based limb restraints; heavy-duty corset or standard buckle closure mechanisms. Mechanical design for physical immobilization. ## 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. Straight Jackets (legally marketed exempt devices) ## 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 K963410 C 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: K963410 Trade Name: Straight Jackets Common Name: Straight Jackets Classification Name: Protective Restraints The devices included in this 510(k) submission limit movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured around the patient via straps. These straps are secured behind the patient with either heavy duty corset buckles or heavy duty standard buckles. These products are intended to limit movement in a hospital patient. The devices used for comparative purposes are identical to the straight jackets 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 straight jackets 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/K963410](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963410) **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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