Who is the manufacturer of CRISS-CROSS VEST RESTRAINT?

Deroyal Industries, Inc. filed the 510(k) submission for CRISS-CROSS VEST RESTRAINT (K963470).

What is the FDA product code for CRISS-CROSS 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 CRISS-CROSS VEST RESTRAINT?

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

What are the predicate devices for CRISS-CROSS VEST RESTRAINT?

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

Who can help prepare an FDA 510(k) submission like CRISS-CROSS 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.

CRISS-CROSS VEST RESTRAINT

K963470 · Deroyal Industries, Inc. · FMQ · Nov 14, 1996 · General Hospital

Device Facts

Record ID	K963470
Device Name	CRISS-CROSS 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. Criss-Cross Vest Restraint 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 Criss-Cross 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 (bed or wheelchair). Operated by healthcare professionals. Comprised of textile vest (cool knit, cotton, or plaid tietex) with polyester straps and nylon hook/loop, plastic, or steel nickel-plated buckles. Device secures patient to bed or wheelchair to prevent falls or injury. Clinical benefit: injury prevention and controlled patient positioning.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: plaid/white tietex, cotton flannel, polyester cool knit, polyester twill tape, white webbing. Fasteners: nylon hook and loop, plastic, or steel nickel-plated buckles. Sizes: S, M, L, XL, XXL. Mechanical restraint device; no energy source or software.

Indications for Use

Indicated for mildly agitated or disoriented patients requiring movement limitation for examination or safety; intended for use with bed or wheelchair under licensed healthcare professional discretion.

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

K963478 — SLEEVED/SLEEVELESS 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
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963467 — ROLL BELTS · Deroyal Industries, Inc. · Jan 3, 1997

Submission Summary (Full Text)

{0} NOV 14 1996 DeRoyal Industries, Inc. Criss-Cross Vest Restraint K9634.70 510(k) Summary SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED SUBMITTER INFORMATION NAME: DeRoyal Industries, Inc. TELEPHONE: (423) 938-7828 ADDRESS: 200 DeBusk Lane CONTACT: Camille Matlock Powell, TN 37849 DATE OF PREPARATION: August 30, 1996 DEVICE NAMES NAME: DeRoyal Industries, Inc. Criss-Cross Vest Restraint COMMON/USUAL NAME: Criss-Cross 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. Criss-Cross 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 Criss-Cross Vest Restraint is designed similar to those marketed by other manufacturers. The Criss-Cross Vest Restraint is primarily comprised of cool knit, cotton, or plaid tietex with polyester straps. The fasteners are made of a nylon hook and loop, plastic, or steel nickel plated buckles. DEVICE INTENDED USE The DeRoyal Industries, Inc. Criss-Cross Vest Restraint 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 Criss-Cross 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, cotton flannel or polyester cool knit. The straps are made of polyester twill tape and white webbing. Fasteners are made of hook and loop, plastic, or steel nickel plated buckles. | Same | | Size | Small, Medium, Large, X-Large, XX-Large | Same | | Vehicles for Attachment | Bed or Wheelchair | Same | | Length of use | Doctor must prescribe every 24 hours | Same | | Level of Patient Activity | Mildly agitated or disoriented Reminder | Same |