← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963463

# STRAIT JACKET (K963463)

_Deroyal Industries, Inc. · FMQ · Oct 16, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963463

## Device Facts

- **Applicant:** Deroyal Industries, Inc.
- **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md)
- **Decision Date:** Oct 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6760
- **Device Class:** Class 1
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

The DeRoyal Industries, Inc. Strait Jacket is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient upper body movements thereby enabling protection of the patient or others.

## Device Story

Protective restraint device; restricts upper body movement to prevent patient self-harm or harm to others. Comprised of white armyduck cotton and steel nickel-plated fasteners. Used in clinical settings under supervision of licensed healthcare professionals. Provides physical control for agitated, disoriented, or aggressive patients. Simple mechanical design; no electronic or software components.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Materials: white armyduck cotton (pre-shrunk), steel nickel-plated fasteners. Form factor: wearable garment in sizes Small, Medium, Large, Extra-Large. Mechanical restraint principle. No energy source, connectivity, 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 Company (unspecified)
- DeRoyal Industries, Inc. (unspecified)

## 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.
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OCT 16 1996
DeRoyal Industries, Inc.
Strait Jacket
X963463
510(k) Summary

# SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

## SUBMITTER INFORMATION

NAME: DeRoyal Industries, Inc.
ADDRESS: 200 DeBusk Lane
Powell, TN 37849
TELEPHONE: (423) 938-7828
CONTACT: Camille Matlock
DATE OF PREPARATION: August 30, 1996

## DEVICE NAMES

NAME: DeRoyal Industries, Inc. Strait Jacket
COMMON/USUAL NAME: Strait Jacket
CLASSIFICATION NAME (if known): Restraint, Protective (80FMQ)

## PREDICATE OR LEGALLY MARKETED DEVICES

J.T. Posey Company
DeRoyal Industries, Inc.

## DEVICE DESCRIPTION

The DeRoyal Industries, Inc. Strait Jacket is a protective restraint device that is intended for medical purposes to restrict patient upper body movements thereby enabling protection of the patient or others.

**Device Design/Materials Used/Physical Properties:** The DeRoyal Strait Jacket is designed similar to those marketed by other manufacturers. The Strait Jacket is primarily comprised of white armyduck cotton and steel nickel plated fasteners.

## DEVICE INTENDED USE

The DeRoyal Industries, Inc. Strait Jacket is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient upper body movements thereby enabling protection of the patient or others.

## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

|  Characteristic | DeRoyal Device | Other Devices  |
| --- | --- | --- |
|  Materials | Primarily comprised of white armyduck cotton
(pre-shrunk) | Same  |
|  Size | Small, Medium, Large, and Extra-Large | Same  |
|  Intended Use | Restrict upper body movement | Same  |
|  Length of use | Short term use | Same  |
|  Level of Patient Activity | Highly Agitated or Disoriented
Aggressive
Patient requires physical control | Same  |

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963463](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963463)

**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).

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