← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963466

# PEDIATRIC LIMB HOLDER (K963466)

_Deroyal Industries, Inc. · FMQ · Feb 13, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963466

## 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:** Feb 13, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6760
- **Device Class:** Class 1
- **Review Panel:** General Hospital
- **Attributes:** Pediatric

## Indications for Use

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

## Device Story

Protective restraint device; limits pediatric limb movement to facilitate medical examination or ensure safety. Comprised of polyester straps with hook and loop fasteners; foam padding (purr foam or kodel). Used in clinical settings (OR, gurney, bed, stretcher). Operated by healthcare professionals; requires physician prescription every 24 hours. Benefits include patient immobilization during procedures or to prevent self-injury.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Materials: 100% polyester twill tape, white webbing, blue purr foam, white kodel. Fasteners: hook and loop. Sizes: infant, child, teen. Attachment: OR table, gurney, bed, stretcher.

## 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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K 963466

DeRoyal Industries, Inc.
Pediatric Limb Holder

FEB 13 1997

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

**Device Design/Materials Used/Physical Properties:** The DeRoyal Pediatric Limb Holder is designed similar to those marketed by other manufacturers. The Pediatric Limb Holder is primarily comprised of polyester straps with hook and loop fasteners.

DEVICE INTENDED USE

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

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

|  Characteristic | DeRoyal Device | Other Devices  |
| --- | --- | --- |
|  Materials | Primarily comprised of 100% polyester twill tape and white webbing. Materials also include blue purr foam or white kodel. Fasteners are made of hook and loop. | Same  |
|  Size | Infant, child, teen | Same  |
|  Vehicles for Attachment | OR Table, gurney, bed, or stretcher | Same  |
|  Length of use | Doctor must prescribe every 24 hours | Same  |
|  Level of Patient Activity | Limb Interference by Pediatric Patient | Same  |

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963466](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963466)

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