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
Attributes
Therapeutic
Indications for 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: (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 |
