ROLL BELTS

K963467 · Deroyal Industries, Inc. · FMQ · Jan 3, 1997 · General Hospital

Device Facts

• Record ID: K963467
• Device Name: ROLL BELTS
• Applicant: Deroyal Industries, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Jan 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Intended Use

The DeRoyal Industries, Inc. Roll Belt 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 DeRoyal Industries, Inc. Roll Belt is intended to be used with a bed.

Device Story

Protective restraint device; limits patient movement while in bed; allows side-to-side movement. Comprised of nylon/polyester webbing, cotton flannel, and foam padding. Fastened via hook-and-loop or buckle. Used in clinical settings; operated by healthcare professionals. Intended to prevent patient injury or protect others during examination/care. Prescribed daily by physicians.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: nylon or polyester seat belt webbing, cotton flannel, foam rubber. Fasteners: hook and loop or buckle. Sizes: Small, Medium, Large. Attachment: bed-mounted. Mechanical restraint device; no energy source or software.

Indications for Use

Indicated for mildly agitated or disoriented patients requiring movement limitation to remain in bed while allowing side-to-side movement for examination or safety. Use requires prescription by a licensed healthcare professional every 24 hours.

Regulatory Classification

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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K963467
JAN. 3, 1997

DeRoyal Industries, Inc.
Roll Belt

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. Roll Belt
COMMON/USUAL NAME: Roll Belt
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. Roll Belt is a protective restraint device that is intended for medical purposes to limit patient movements so that the patient remains in the bed while allowing the patient to move from side to side thereby enabling examination or protection of the patient or others.

Device Design/Materials Used/Physical Properties: The DeRoyal Roll Belt is designed similar to those marketed by other manufacturers. The Roll Belt is primarily comprised of nylon or polyester seat belt webbing and cotton flannel.

DEVICE INTENDED USE
The DeRoyal Industries, Inc. Roll Belt 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 DeRoyal Industries, Inc. Roll Belt is intended to be used with a bed.

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
| --- | --- | --- |
| Materials | Primarily comprised of nylon or polyester seat belt webbing. Materials also include cotton flannel and foam rubber for soft padding. Fasteners are either a hook and loop or a buckle. | Same |
| Size | Small, Medium, and Large | Same |
| Vehicles for Attachment | Bed | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | Mildly Agitated or disoriented | Same |

ISN