Who is the manufacturer of SUPER SECURITY RESTRAINT?

Deroyal Industries, Inc. filed the 510(k) submission for SUPER SECURITY RESTRAINT (K963471).

What is the FDA product code for SUPER SECURITY 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 SUPER SECURITY RESTRAINT?

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

What are the predicate devices for SUPER SECURITY RESTRAINT?

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

Who can help prepare an FDA 510(k) submission like SUPER SECURITY 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.

SUPER SECURITY RESTRAINT

K963471 · Deroyal Industries, Inc. · FMQ · Nov 14, 1996 · General Hospital

Device Facts

Record ID	K963471
Device Name	SUPER SECURITY 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
Attributes	Therapeutic

Intended Use

The DeRoyal Industries, Inc. Super Security Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby providing postural support or enabling examination or protection of the patient or others. The Super Security Restraint is a protective restraint which can be used with a bed or wheelchair.

Device Story

Protective restraint device; limits patient movement for postural support, examination, or safety. Comprised of cool knit polyester material; vest-style design with optional pelvic holder. Used in clinical settings (beds or wheelchairs); operated by healthcare professionals. Provides physical restriction to prevent patient from leaving bed/wheelchair. Benefits include patient safety and facilitation of medical care.

Clinical Evidence

No clinical data provided; equivalence based on design and material similarity to legally marketed predicate devices.

Technological Characteristics

Materials: Cool knit polyester body, polyester binding/straps. Form factor: Vest with optional pelvic holder. Attachment: Bed or wheelchair. Mechanical restraint principle.

Indications for Use

Indicated for mildly agitated or disoriented patients with a tendency to leave bed or wheelchair; used to limit movement for postural support, examination, or protection of patient/others; 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 (unspecified)
DeRoyal Industries, Inc. (unspecified)

Related Devices

K963470 — CRISS-CROSS VEST RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
K963478 — SLEEVED/SLEEVELESS VEST RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K972123 — PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 · Smith · Jul 25, 1997
K963430 — PROTECTIVE RESTRAINT (VEST RESTRAINT) · Kenad SG Medical, Inc. · Nov 22, 1996

Submission Summary (Full Text)

{0} NOV 14 1996 DeRoyal Industries, Inc. Super Security Restraint 510(k) Summary $K963971$ # 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. Super Security Restraint COMMON/USUAL NAME: Security 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. Super Security Restraint is a protective restraint device that is intended for medical purposes to limit patient movements thereby providing postural support or enabling examination or protection of the patient or others. **Device Design/Materials Used/Physical Properties:** The DeRoyal Super Security Restraint is designed similar to those marketed by other manufacturers. The Super Security Restraint is primarily comprised of cool knit material. ## DEVICE INTENDED USE The DeRoyal Industries, Inc. Super Security Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby providing postural support or enabling examination or protection of the patient or others. The Super Security Restraint is a protective restraint which can be used with a bed or wheelchair. ## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | The body is comprised of Cool Knit (polyester). The binding and straps are made of polyester. | Same | | Style Variations | Vest with Pelvic Holder or Vest Only | 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 Tendency to Leave Bed or Wheelchair | Same |