← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963476

# DISPOSABLE LIMB HOLDER (K963476)

_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/K963476

## 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. Disposable Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination or protection of the patient or others. The Disposable Limb Holder can be used with a gurney, bed, or stretcher.

## Device Story

Disposable limb holder; protective restraint device. Limits limb movement to facilitate examination or ensure safety of patient/others. Used in clinical settings (beds, gurneys, stretchers). Operated by healthcare professionals. Constructed from kodel, nylon, flannel, or blue purr material; white webbing straps; hook and loop or steel nickel-plated buckle fasteners. Universal size. Prescribed by physician every 24 hours.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Materials: kodel, nylon, flannel, blue purr; white webbing straps. Fasteners: hook and loop or steel nickel-plated buckles. Universal size. Non-powered, mechanical restraint 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 (unspecified)
- DeRoyal Industries, Inc. (unspecified)

## Submission Summary (Full Text)

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DeRoyal Industries, Inc.
Disposable Limb Holder
510(k) Summary
K 9634 76
JAN 22 1997

# 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. Disposable Limb Holder
COMMON/USUAL NAME: Disposable Limb 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. Disposable Limb Holder is a protective restraint device that is intended for medical purposes to limit limb movements thereby enabling examination or protection of the patient or others.

**Device Design/Materials Used/Physical Properties:** The DeRoyal Disposable Limb Holder is designed similar to those marketed by other manufacturers. The Disposable Limb Holder is primarily comprised of a kodel, nylon, flannel or blue purr material. The straps are made of white webbing. The fasteners are made of hook and loop or steel nickel plated buckles.

## DEVICE INTENDED USE

The DeRoyal Industries, Inc. Disposable Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination or protection of the patient or others. The Disposable Limb Holder can be used with a gurney, bed, or stretcher.

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

|  Characteristic | DeRoyal Device | Other Devices  |
| --- | --- | --- |
|  Materials | Primarily comprised of kodel, nylon, flannel or blue purr material. The straps are made of white webbing. Fasteners include hook and loop or buckles. | Same  |
|  Size | Universal | Same  |
|  Vehicles for Attachment | Gurney, Bed, or Stretcher | Same  |
|  Length of use | Doctor must prescribe every 24 hours | Same  |
|  Level of Patient Activity | Mildly to moderately agitated or disoriented | Same  |

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963476](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963476)

**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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