← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963465

# PELVIC HOLDER (K963465)

_Deroyal Industries, Inc. · FMQ · Dec 19, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963465

## 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:** Dec 19, 1996
- **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. Pelvic Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movement thereby enabling examination or protection of the patient or others. The Pelvic Holder is a protective restraint which can be used with a bed or wheelchair.

## Device Story

Pelvic holder; protective restraint device. Limits patient movement to facilitate examination or ensure safety of patient/others. Used in clinical settings (beds or wheelchairs). Operated by healthcare professionals. Comprised of cotton cloth, flannel, cool knit, or cotton sheeting. Available in disposable or extra security styles. Prescribed by physician every 24 hours.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Materials: cotton cloth, flannel, cool knit, or cotton sheeting. Form factor: pelvic restraint strap. Attachment: bed or wheelchair. Styles: disposable or extra security.

## 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)

> 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}

DEC 19 1996

DeRoyal Industries, Inc.
Pelvic 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. Pelvic Holder
COMMON/USUAL NAME: Pelvic 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. Pelvic Holder is a protective restraint device that is intended for medical purposes to limit patient movement thereby enabling examination or protection of the patient or others.
**Device Design/Materials Used/Physical Properties**: The DeRoyal Pelvic Holder is designed similar to those marketed by other manufacturers. The Pelvic Holder is primarily comprised of either cotton cloth, flannel, cool knit, or cotton sheeting.

DEVICE INTENDED USE
The DeRoyal Industries, Inc. Pelvic Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movement thereby enabling examination or protection of the patient or others.
The Pelvic 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 | The body is comprised of either cotton cloth, flannel, cool knit, or cotton sheeting | Same  |
|  Style Variations | Disposable or Extra Security | Same  |
|  Vehicles for Attachment | Bed or Wheelchair | Same  |
|  Length of use | Doctor must prescribe every 24 hours | Same  |
|  Level of Patient Activity | Mildly Agitated or Disoriented
Tendency to Leave Bed or Wheelchair | Same  |

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963465](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963465)

**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).

**Cite:** Innolitics at https://innolitics.com