← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963464

# RESTRAINT NET (K963464)

_Deroyal Industries, Inc. · FMQ · Nov 12, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963464

## 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:** Nov 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6760
- **Device Class:** Class 1
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

The DeRoyal Industries, Inc. Restraint Net is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient body movements thereby enabling protection of the patient or others. The Restraint Net/Bed is intended to be attached to a bed. The Restraint Net/Stretcher is intended to be attached to a stretcher.

## Device Story

Protective restraint device; restricts patient body movement to ensure safety of patient or others. Comprised of white mesh, polyester webbing straps, and steel nickel-plated fasteners. Used in clinical settings (beds/stretchers); operated by healthcare professionals. Provides physical containment for agitated or aggressive patients.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Materials: white mesh, 100% polyester webbing straps, steel nickel-plated fasteners. Form factor: universal size net. Attachment: bed or stretcher-mounted. Mechanical restraint device; no energy source or software.

## 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
- DeRoyal Industries, Inc.

## Submission Summary (Full Text)

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K 96 3464

DeRoyal Industries, Inc.

Restraint Net

NOV 12 1996

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. Restraint Net
COMMON/USUAL NAME: Restraint Net
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. Restraint Net is a protective restraint device that is intended for medical purposes to restrict patient body movements thereby enabling protection of the patient or others.

**Device Design/Materials Used/Physical Properties:** The DeRoyal Restraint Net is designed similar to those marketed by other manufacturers. The Restraint Net is primarily comprised of white mesh.

## DEVICE INTENDED USE

The DeRoyal Industries, Inc. Restraint Net is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient body movements thereby enabling protection of the patient or others. The Restraint Net/Bed is intended to be attached to a bed. The Restraint Net/Stretcher is intended to be attached to a stretcher.

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

|  Characteristic | DeRoyal Device | Other Devices  |
| --- | --- | --- |
|  Materials | Primarily comprised of white mesh, white webbing straps (100% polyester), and steel nickel plated fasteners | Same  |
|  Size | Universal | Same  |
|  Vehicles for Attachment | Restraint Net/Bed: Bed
Restraint Net/Stretcher: Stretcher | Same  |
|  Length of use | Short term use | Same  |
|  Level of Patient Activity | Highly Agitated or Disoriented
Aggressive
Patient requires physical control | Same  |

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963464](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963464)

**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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