Who is the manufacturer of SLEEVED/SLEEVELESS VEST RESTRAINT?

Deroyal Industries, Inc. filed the 510(k) submission for SLEEVED/SLEEVELESS VEST RESTRAINT (K963478).

What is the FDA product code for SLEEVED/SLEEVELESS 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 SLEEVED/SLEEVELESS VEST RESTRAINT?

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

Who can help prepare an FDA 510(k) submission like SLEEVED/SLEEVELESS 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.

SLEEVED/SLEEVELESS VEST RESTRAINT

Q: What are the predicate devices for SLEEVED/SLEEVELESS VEST RESTRAINT?

J.T. Posey Company; DeRoyal Industries, Inc..

K963478 · Deroyal Industries, Inc. · FMQ · Nov 14, 1996 · General Hospital

Device Facts

Record ID	K963478
Device Name	SLEEVED/SLEEVELESS VEST RESTRAINT
Applicant	Deroyal Industries, Inc.
Product Code	FMQ · General Hospital
Decision Date	Nov 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1

Intended Use

The DeRoyal Industries, Inc. Sleeved/ Sleeveless 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 Sleeved/ Sleeveless 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 of patient/others. Used in clinical settings (beds/wheelchairs). Operated by healthcare professionals. Design consists of vest (sleeved/sleeveless) secured via straps to bed or wheelchair. Fastened using nylon hook/loop or steel nickel-plated buckles. Benefits include prevention of patient injury or interference with medical care.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: tietex, cotton flannel, polyester cool knit, polyester twill tape, white webbing. Fasteners: nylon hook and loop or steel nickel-plated buckles. Sizes: XS to XXXL. Attachment: bed or wheelchair. Non-powered, mechanical device.

Indications for Use

Indicated for mildly to moderately agitated or disoriented patients requiring movement limitation for examination or protection of patient/others; used with bed or wheelchair; requires prescription by licensed healthcare professional every 24 hours.

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
DeRoyal Industries, Inc.

Related Devices

K963470 — CRISS-CROSS VEST RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
K963471 — SUPER SECURITY RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
K972123 — PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 · Smith · Jul 25, 1997
K963474 — TUXEDO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963430 — PROTECTIVE RESTRAINT (VEST RESTRAINT) · Kenad SG Medical, Inc. · Nov 22, 1996

Submission Summary (Full Text)

{0} NOV 14 1996 K963478 DeRoyal Industries, Inc. Sleeved/ Sleeveless 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. Sleeved/ Sleeveless Vest Restraint COMMON/USUAL NAME: Sleeved/ Sleeveless 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. Sleeved/ Sleeveless Vest Restraint 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 Sleeved/ Sleeveless Vest Restraint is designed similar to those marketed by other manufacturers. The Sleeved/ Sleeveless Restraint is primarily comprised of cool knit, cotton, or with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles. DEVICE INTENDED USE The DeRoyal Industries, Inc. Sleeved/ Sleeveless 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 Sleeved/ Sleeveless 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 tietex, cotton flannel or polyester cool knit. The straps are made of polyester twill tape and white webbing. Fasteners are made of hook and loop or steel nickel plated buckles. | 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 | Mildly to moderately agitated or disoriented | Same |