← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963468

# RESTRICTIVE LIMB HOLDER (K963468)

_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/K963468

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

## Device Story

Protective restraint device; limits limb movement for patient/staff safety during examination. Comprised of leather, neoprene, soft kodel, and webbing straps; utilizes hook and loop, delrin, and steel nickel-plated fasteners. Universal size; attaches to gurneys, beds, or stretchers. Operated by healthcare professionals; requires 24-hour prescription renewal. Benefits include controlled patient movement in clinical settings.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Materials: leather, neoprene, soft kodel, nylon/polyester webbing. Fasteners: hook and loop, delrin, steel nickel-plated. Form factor: universal size limb restraint. Energy source: none (mechanical).

## 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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{0}

JAN 22 1997
K963468

DeRoyal Industries, Inc.
Restrictive Limb 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. Restrictive Limb Holder
COMMON/USUAL NAME: Restrictive 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. Restrictive 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 Restrictive Limb Holder is designed similar to those marketed by other manufacturers. The Restrictive Limb Holder is primarily comprised of leather, neoprene, and soft kodel with nylon or polyester webbing straps. The types of fasteners include hook and loop, delrin, and various types that are steel nickel plated.

DEVICE INTENDED USE
The DeRoyal Industries, Inc. Restrictive Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to substantially limit patient limb movements thereby enabling examination or protection of the patient or others. The Restrictive 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 leather, neoprene, and soft kodel material with webbing straps. The types of fasteners include hook and loop, delrin, and various types that are steel nickel plated | 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 | Highly agitated or violent | Same  |

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963468](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963468)

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