Who is the manufacturer of RESTRICTIVE LIMB HOLDER?

Deroyal Industries, Inc. submitted the Traditional clearance for RESTRICTIVE LIMB HOLDER (K963468).

What is the FDA product code for RESTRICTIVE LIMB HOLDER?

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 RESTRICTIVE LIMB HOLDER?

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

What are the predicate devices for RESTRICTIVE LIMB HOLDER?

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

RESTRICTIVE LIMB HOLDER

K963468 · Deroyal Industries, Inc. · FMQ · Jan 22, 1997 · General Hospital

Device Facts

Record ID	K963468
Device Name	RESTRICTIVE LIMB HOLDER
Applicant	Deroyal Industries, Inc.
Product Code	FMQ · General Hospital
Decision Date	Jan 22, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1

Intended Use

The DeRoyal Industries, Inc. Restrictive Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to substantially limit patient limb movements thereby enabling examination or protection of the patient or others. The Restrictive Limb Holder can be used with a gurney, bed, or stretcher.

Device Story

Protective restraint device; limits limb movement for patient/staff safety during examination. Comprised of leather, neoprene, soft kodel, and webbing straps; utilizes hook and loop, delrin, and steel nickel-plated fasteners. Universal size; attaches to gurneys, beds, or stretchers. Operated by healthcare professionals; requires 24-hour prescription renewal. Benefits include controlled patient movement in clinical settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: leather, neoprene, soft kodel, nylon/polyester webbing. Fasteners: hook and loop, delrin, steel nickel-plated. Form factor: universal size limb restraint. Energy source: none (mechanical).

Indications for Use

Indicated for highly agitated or violent patients requiring limb movement restriction to facilitate medical examination or ensure safety of patient/others. Use requires prescription by a 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 (not specified)
DeRoyal Industries, Inc. (not specified)

Related Devices

K963473 — REUSABLE LIMB HOLDER · Deroyal Industries, Inc. · Nov 14, 1996
K963476 — DISPOSABLE LIMB HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
K963466 — PEDIATRIC LIMB HOLDER · Deroyal Industries, Inc. · Feb 13, 1997
K963474 — TUXEDO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997

Submission Summary (Full Text)

{0} JAN 22 1997 K963468 DeRoyal Industries, Inc. Restrictive Limb Holder 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. Restrictive Limb Holder COMMON/USUAL NAME: Restrictive Limb Holder 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. Restrictive Limb Holder is a protective restraint device that is intended for medical purposes to limit limb movements thereby enabling examination or protection of the patient or others. Device Design/Materials Used/Physical Properties: The DeRoyal Restrictive Limb Holder is designed similar to those marketed by other manufacturers. The Restrictive Limb Holder is primarily comprised of leather, neoprene, and soft kodel with nylon or polyester webbing straps. The types of fasteners include hook and loop, delrin, and various types that are steel nickel plated. DEVICE INTENDED USE The DeRoyal Industries, Inc. Restrictive Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to substantially limit patient limb movements thereby enabling examination or protection of the patient or others. The Restrictive Limb Holder can be used with a gurney, bed, or stretcher. TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | Primarily comprised of leather, neoprene, and soft kodel material with webbing straps. The types of fasteners include hook and loop, delrin, and various types that are steel nickel plated | Same | | Size | Universal | Same | | Vehicles for Attachment | Gurney, Bed, or Stretcher | Same | | Length of use | Doctor must prescribe every 24 hours | Same | | Level of Patient Activity | Highly agitated or violent | Same |