Who is the manufacturer of STRAIT JACKET?

Deroyal Industries, Inc. filed the 510(k) submission for STRAIT JACKET (K963463).

What is the FDA product code for STRAIT JACKET?

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 STRAIT JACKET?

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

What are the predicate devices for STRAIT JACKET?

J.T. Posey Company (unspecified); DeRoyal Industries, Inc. (unspecified).

Who can help prepare an FDA 510(k) submission like STRAIT JACKET?

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.

STRAIT JACKET

K963463 · Deroyal Industries, Inc. · FMQ · Oct 16, 1996 · General Hospital

Device Facts

Record ID	K963463
Device Name	STRAIT JACKET
Applicant	Deroyal Industries, Inc.
Product Code	FMQ · General Hospital
Decision Date	Oct 16, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1
Attributes	Therapeutic

Intended Use

The DeRoyal Industries, Inc. Strait Jacket is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient upper body movements thereby enabling protection of the patient or others.

Device Story

Protective restraint device; restricts upper body movement to prevent patient self-harm or harm to others. Comprised of white armyduck cotton and steel nickel-plated fasteners. Used in clinical settings under supervision of licensed healthcare professionals. Provides physical control for agitated, disoriented, or aggressive patients. Simple mechanical design; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: white armyduck cotton (pre-shrunk), steel nickel-plated fasteners. Form factor: wearable garment in sizes Small, Medium, Large, Extra-Large. Mechanical restraint principle. No energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring upper body movement restriction for protection of self or others; intended for use by licensed healthcare professionals; applicable for highly agitated, disoriented, or aggressive patients requiring physical control.

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 (unspecified)
DeRoyal Industries, Inc. (unspecified)

Related Devices

K963464 — RESTRAINT NET · Deroyal Industries, Inc. · Nov 12, 1996
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
K972123 — PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 · Smith · Jul 25, 1997
K963474 — TUXEDO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997

Submission Summary (Full Text)

{0} OCT 16 1996 DeRoyal Industries, Inc. Strait Jacket X963463 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. Strait Jacket COMMON/USUAL NAME: Strait Jacket 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. Strait Jacket is a protective restraint device that is intended for medical purposes to restrict patient upper body movements thereby enabling protection of the patient or others. **Device Design/Materials Used/Physical Properties:** The DeRoyal Strait Jacket is designed similar to those marketed by other manufacturers. The Strait Jacket is primarily comprised of white armyduck cotton and steel nickel plated fasteners. ## DEVICE INTENDED USE The DeRoyal Industries, Inc. Strait Jacket is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient upper body movements thereby enabling protection of the patient or others. ## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | Primarily comprised of white armyduck cotton (pre-shrunk) | Same | | Size | Small, Medium, Large, and Extra-Large | Same | | Intended Use | Restrict upper body movement | Same | | Length of use | Short term use | Same | | Level of Patient Activity | Highly Agitated or Disoriented Aggressive Patient requires physical control | Same |