← Product Code [KID](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KID) · K963480

# MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (K963480)

_Deroyal Industries, Inc. · KID · Jan 22, 1997 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KID/K963480

## Device Facts

- **Applicant:** Deroyal Industries, Inc.
- **Product Code:** [KID](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KID.md)
- **Decision Date:** Jan 22, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3910
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Indications for Use

The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient or others. The Multi-Purpose Utility Restraint can be used with an OR table, gurney, bed, or stretcher. The Body Holder is a protective restraint which can be used with a bed or wheelchair.

## Device Story

Protective restraint device; limits patient movement for examination or safety. Used with OR tables, gurneys, beds, or wheelchairs. Operated by healthcare professionals. Comprised of nylon or cotton; includes foam, binding, and webbing. Provides physical stabilization to prevent patient injury or interference with medical procedures.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Materials: nylon, cotton, blue purr foam, white binding, webbing. Form factor: universal size. Attachment: OR table, gurney, bed, stretcher, or wheelchair. Non-powered, mechanical restraint.

## Regulatory Identification

A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.

## 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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JAN 22 1997
X963480

# DeRoyal Industries, Inc.
## Multi-Purpose Utility Restraint/ Body Holder
### 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. Multi-Purpose Utility Restraint/ Body Holder
COMMON/USUAL NAME: Utility Restraint/ Body Holder
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. Multi-Purpose Utility Restraint / Body Holder is a protective restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others.

**Device Design/Materials Used/Physical Properties:** The DeRoyal Multi-Purpose Utility Restraint/ Body Holder is designed similar to those marketed by other manufacturers. The Multi-Purpose Utility Restraint/ Body Holder is primarily comprised of nylon or cotton.

## DEVICE INTENDED USE

The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient or others. The Multi-Purpose Utility Restraint can be used with an OR table, gurney, bed, or stretcher. The Body Holder is a protective restraint which can 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 nylon or cotton.
Materials also include blue purr foam, white binding, and webbing. | Same  |
|  Size | Universal | Same  |
|  Vehicles for Attachment | **Body Holder:** Bed or Wheelchair
**Multi-Purpose Utility Restraint:** OR Table, Gurney, Bed, or Stretcher | Same  |
|  Length of use | Doctor must prescribe every 24 hours | Same  |
|  Level of Patient Activity | Mildly Agitated or Disoriented
Surgical Patient
Patient Transport | Same  |

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KID/K963480](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KID/K963480)

**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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