K963479 · Deroyal Industries, Inc. · KID · Jan 24, 1997 · Physical Medicine
Device Facts
Record ID
K963479
Device Name
WHEELCHAIR BELT
Applicant
Deroyal Industries, Inc.
Product Code
KID · Physical Medicine
Decision Date
Jan 24, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 890.3910
Device Class
Class 1
Attributes
Therapeutic
Indications for Use
The DeRoyal Industries, Inc. Wheelchair 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. Wheelchair Belt is intended to be used with a wheelchair only.
Device Story
Protective restraint device; limits patient movement in wheelchairs to prevent sliding; aids in patient examination or protection. Comprised of nylon or polyester seat belt webbing with blue purr and foam rubber padding; utilizes hook and loop or buckle fasteners. Used in clinical or care settings; operated by healthcare professionals. Prescribed by physicians; intended for patients prone to sliding. Benefits include patient safety and stability during wheelchair use.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Materials: nylon or polyester seat belt webbing, blue purr, foam rubber. Fasteners: hook and loop or buckle. Form factor: universal size. Energy source: none (mechanical).
Indications for Use
Indicated for patients in wheelchairs requiring movement limitation for examination or protection, at the discretion of 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 (not specified)
DeRoyal Industries, Inc. (not specified)
Submission Summary (Full Text)
{0}
JAN 24 1997
DeRoyal Industries, Inc.
Wheelchair Belt
510(k) Summary
K963479
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. Wheelchair Belt
COMMON/USUAL NAME: Wheelchair 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. Wheelchair Belt is a protective restraint device that is intended for medical purposes to limit patient movements thereby helping prevent the patient from sliding in a wheelchair.
Device Design/Materials Used/Physical Properties: The DeRoyal Wheelchair Belt is designed similar to those marketed by other manufacturers. The Wheelchair Belt is primarily comprised of nylon or polyester seat belt webbing.
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Wheelchair 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. Wheelchair Belt is intended to be used with a wheelchair only.
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 blue purr and foam rubber for soft padding. Fasteners are either a hook and loop or a buckle. | Same |
| Size | Universal | Same |
| Vehicles for Attachment | Wheelchair | Same |
| Length of use | Doctor must prescribe every 24 hours | Same |
| Level of Patient Activity | For patients that tend to slide in their chairs | Same |
