Who is the manufacturer of RESTRAINT NET?

Deroyal Industries, Inc. filed the 510(k) submission for RESTRAINT NET (K963464).

What is the FDA product code for RESTRAINT NET?

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 RESTRAINT NET?

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

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

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.

RESTRAINT NET

Q: What are the predicate devices for RESTRAINT NET?

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

K963464 · Deroyal Industries, Inc. · FMQ · Nov 12, 1996 · General Hospital

Device Facts

Record ID	K963464
Device Name	RESTRAINT NET
Applicant	Deroyal Industries, Inc.
Product Code	FMQ · General Hospital
Decision Date	Nov 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1
Attributes	Therapeutic

Intended Use

The DeRoyal Industries, Inc. Restraint Net is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient body movements thereby enabling protection of the patient or others. The Restraint Net/Bed is intended to be attached to a bed. The Restraint Net/Stretcher is intended to be attached to a stretcher.

Device Story

Protective restraint device; restricts patient body movement to ensure safety of patient or others. Comprised of white mesh, polyester webbing straps, and steel nickel-plated fasteners. Used in clinical settings (beds/stretchers); operated by healthcare professionals. Provides physical containment for agitated or aggressive patients.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: white mesh, 100% polyester webbing straps, steel nickel-plated fasteners. Form factor: universal size net. Attachment: bed or stretcher-mounted. Mechanical restraint device; no energy source or software.

Indications for Use

Indicated for highly agitated, disoriented, or aggressive patients requiring physical control to prevent harm to self or others; for use at discretion of licensed healthcare professional; attaches to beds or stretchers.

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

K963463 — STRAIT JACKET · Deroyal Industries, Inc. · Oct 16, 1996
K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
K962429 — SAFETY VEST · Johnson & Johnson Professionals, Inc. · Sep 18, 1996
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963471 — SUPER SECURITY RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996

Submission Summary (Full Text)

{0} K 96 3464 DeRoyal Industries, Inc. Restraint Net NOV 12 1996 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. Restraint Net COMMON/USUAL NAME: Restraint Net 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. Restraint Net is a protective restraint device that is intended for medical purposes to restrict patient body movements thereby enabling protection of the patient or others. **Device Design/Materials Used/Physical Properties:** The DeRoyal Restraint Net is designed similar to those marketed by other manufacturers. The Restraint Net is primarily comprised of white mesh. ## DEVICE INTENDED USE The DeRoyal Industries, Inc. Restraint Net is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient body movements thereby enabling protection of the patient or others. The Restraint Net/Bed is intended to be attached to a bed. The Restraint Net/Stretcher is intended to be attached to a stretcher. ## TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | Primarily comprised of white mesh, white webbing straps (100% polyester), and steel nickel plated fasteners | Same | | Size | Universal | Same | | Vehicles for Attachment | Restraint Net/Bed: Bed Restraint Net/Stretcher: Stretcher | Same | | Length of use | Short term use | Same | | Level of Patient Activity | Highly Agitated or Disoriented Aggressive Patient requires physical control | Same |