Who is the manufacturer of TUXEDO VEST RESTRAINT?

Deroyal Industries, Inc. filed the 510(k) submission for TUXEDO VEST RESTRAINT (K963474).

What is the FDA product code for TUXEDO VEST RESTRAINT?

FMQ. It is classified under 21 CFR 880.6760 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for TUXEDO VEST RESTRAINT?

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

What are the predicate devices for TUXEDO VEST RESTRAINT?

J.T. Posey Company (not specified); DeRoyal Industries, Inc. (not specified).

Who can help prepare an FDA 510(k) submission like TUXEDO VEST RESTRAINT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TUXEDO VEST RESTRAINT

K963474 · Deroyal Industries, Inc. · FMQ · Jan 22, 1997 · General Hospital

Device Facts

Record ID	K963474
Device Name	TUXEDO VEST RESTRAINT
Applicant	Deroyal Industries, Inc.
Product Code	FMQ · General Hospital
Decision Date	Jan 22, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1

Intended Use

The DeRoyal Industries, Inc. Tuxedo Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Tuxedo Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.

Device Story

Protective restraint device; limits patient movement to facilitate examination or ensure safety. Comprised of tietex fabric and polyester straps with nylon hook-and-loop or plastic fasteners. Used in clinical settings (beds or wheelchairs). Operated by healthcare professionals; requires physician prescription every 24 hours. Benefits include preventing patient injury or unauthorized exit from bed/wheelchair.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: white or plaid tietex, polyester straps, nylon hook-and-loop or plastic fasteners. Form factor: vest restraint available in sizes X-Small through XXX-Large. Attachment: bed or wheelchair. Non-powered, mechanical device.

Indications for Use

Indicated for moderately agitated or disoriented patients, or those prone to sliding or attempting to exit a bed or wheelchair, to limit movement for examination or protection of the patient or others, as prescribed by a licensed healthcare professional.

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 (not specified)
DeRoyal Industries, Inc. (not specified)

Related Devices

K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963469 — MITTENS · Deroyal Industries, Inc. · Nov 14, 1996
K963467 — ROLL BELTS · Deroyal Industries, Inc. · Jan 3, 1997
K963470 — CRISS-CROSS VEST RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
K963478 — SLEEVED/SLEEVELESS VEST RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996

Submission Summary (Full Text)

{0} K963474 Jan. 22, 1997 DeRoyal Industries, Inc. Tuxedo Vest Restraint 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. Tuxedo Vest Restraint COMMON/USUAL NAME: Tuxedo Vest Restraint 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. Tuxedo Vest Restraint is a protective restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others. **Device Design/Materials Used/Physical Properties:** The DeRoyal Tuxedo Vest Restraint is designed similar to those marketed by other manufacturers. The Tuxedo Restraint is primarily comprised of white or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop or plastic. DEVICE INTENDED USE The DeRoyal Industries, Inc. Tuxedo Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Tuxedo Vest Restraint is a protective restraint that is intended to 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 plaid or white tietex and polyester straps. Fasteners are made of hook and loop or plastic. | Same | | Size | X-Small, Small, Medium, Large, X-Large, XX-Large, XXX-Large | Same | | Vehicles for Attachment | Bed or Wheelchair | Same | | Length of use | Doctor must prescribe every 24 hours | Same | | Level of Patient Activity | Moderately agitated or disoriented Prone to sliding Actively trying to get out of bed or wheelchair | Same |