MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER

K963480 · Deroyal Industries, Inc. · KID · Jan 22, 1997 · Physical Medicine

Device Facts

• Record ID: K963480
• Device Name: MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
• Applicant: Deroyal Industries, Inc.
• Product Code: KID · Physical Medicine
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3910
• Device Class: Class 1

Intended Use

The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient or others. The Multi-Purpose Utility Restraint can be used with an OR table, gurney, bed, or stretcher. The Body Holder is a protective restraint which can be used with a bed or wheelchair.

Device Story

Protective restraint device; limits patient movement for examination or safety. Used with OR tables, gurneys, beds, or wheelchairs. Operated by healthcare professionals. Comprised of nylon or cotton; includes foam, binding, and webbing. Provides physical stabilization to prevent patient injury or interference with medical procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: nylon, cotton, blue purr foam, white binding, webbing. Form factor: universal size. Attachment: OR table, gurney, bed, stretcher, or wheelchair. Non-powered, mechanical restraint.

Indications for Use

Indicated for mildly agitated, disoriented, surgical, or transport patients requiring movement limitation for examination or safety, as prescribed by a licensed healthcare professional.

Regulatory Classification

Identification

A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.

Predicate Devices

• J.T. Posey Company (unspecified)
• DeRoyal Industries, Inc. (unspecified)

Submission Summary (Full Text)

{0}

JAN 22 1997
X963480

# DeRoyal Industries, Inc.
## Multi-Purpose Utility Restraint/ Body 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: [phone]
CONTACT: Camille Matlock
DATE OF PREPARATION: August 30, 1996

## DEVICE NAMES

NAME: DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder
COMMON/USUAL NAME: Utility Restraint/ Body 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. Multi-Purpose Utility Restraint / Body Holder is a protective restraint device that is intended for medical purposes to limit patient movements thereby enabling examination or protection of the patient or others.

**Device Design/Materials Used/Physical Properties:** The DeRoyal Multi-Purpose Utility Restraint/ Body Holder is designed similar to those marketed by other manufacturers. The Multi-Purpose Utility Restraint/ Body Holder is primarily comprised of nylon or cotton.

## DEVICE INTENDED USE

The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enabling examination or protection of the patient or others. The Multi-Purpose Utility Restraint can be used with an OR table, gurney, bed, or stretcher. The Body 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 | Primarily comprised of nylon or cotton.
Materials also include blue purr foam, white binding, and webbing. | Same |
| Size | Universal | Same |
| Vehicles for Attachment | **Body Holder:** Bed or Wheelchair
**Multi-Purpose Utility Restraint:** OR Table, Gurney, Bed, or Stretcher | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Mildly Agitated or Disoriented
Surgical Patient
Patient Transport | Same |