← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963474

# TUXEDO VEST RESTRAINT (K963474)

_Deroyal Industries, Inc. · FMQ · Jan 22, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963474

## 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:** Jan 22, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6760
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

The DeRoyal Industries, Inc. Tuxedo Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Tuxedo Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.

## Device Story

Protective restraint device; limits patient movement to facilitate examination or ensure safety. Comprised of tietex fabric and polyester straps with nylon hook-and-loop or plastic fasteners. Used in clinical settings (beds or wheelchairs). Operated by healthcare professionals; requires physician prescription every 24 hours. Benefits include preventing patient injury or unauthorized exit from bed/wheelchair.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Materials: white or plaid tietex, polyester straps, nylon hook-and-loop or plastic fasteners. Form factor: vest restraint available in sizes X-Small through XXX-Large. Attachment: bed or wheelchair. Non-powered, mechanical device.

## 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 (not specified)
- DeRoyal Industries, Inc. (not specified)

## Submission Summary (Full Text)

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K963474
Jan. 22, 1997

DeRoyal Industries, Inc.
Tuxedo Vest Restraint
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. Tuxedo Vest Restraint
COMMON/USUAL NAME: Tuxedo Vest Restraint
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. Tuxedo Vest Restraint is a protective restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others.
**Device Design/Materials Used/Physical Properties:** The DeRoyal Tuxedo Vest Restraint is designed similar to those marketed by other manufacturers. The Tuxedo Restraint is primarily comprised of white or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop or plastic.

DEVICE INTENDED USE
The DeRoyal Industries, Inc. Tuxedo Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Tuxedo Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

|  Characteristic | DeRoyal Device | Other Devices  |
| --- | --- | --- |
|  Materials | Primarily comprised of plaid or white tietex and polyester straps. Fasteners are made of hook and loop or plastic. | Same  |
|  Size | X-Small, Small, Medium, Large, X-Large, XX-Large, XXX-Large | Same  |
|  Vehicles for Attachment | Bed or Wheelchair | Same  |
|  Length of use | Doctor must prescribe every 24 hours | Same  |
|  Level of Patient Activity | Moderately agitated or disoriented
Prone to sliding
Actively trying to get out of bed or wheelchair | Same  |

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963474](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963474)

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