WHEELCHAIR BELT
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 |
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.
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)
Related Devices
- K963470 — CRISS-CROSS VEST RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
- K963471 — SUPER SECURITY RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
- K963474 — TUXEDO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
- K963060 — HEELBO SECURITY BELT · Heelbo, Inc. · Nov 4, 1996
- K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
