Who is the manufacturer of MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER?

Deroyal Industries, Inc. submitted the Traditional clearance for MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (K963480).

What is the FDA product code for MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER?

KID. It is classified under 21 CFR 890.3910 as a Class 1 device in the Physical Medicine panel.

What is the regulatory pathway for MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER?

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

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)

Related Devices

K963467 — ROLL BELTS · Deroyal Industries, Inc. · Jan 3, 1997
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963464 — RESTRAINT NET · Deroyal Industries, Inc. · Nov 12, 1996
K963474 — TUXEDO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963471 — SUPER SECURITY RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996

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: (423) 938-7828 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 |