Who is the manufacturer of REUSABLE LIMB HOLDER?

Deroyal Industries, Inc. filed the 510(k) submission for REUSABLE LIMB HOLDER (K963473).

What is the FDA product code for REUSABLE 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 REUSABLE LIMB HOLDER?

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

What are the predicate devices for REUSABLE LIMB HOLDER?

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

Who can help prepare an FDA 510(k) submission like REUSABLE LIMB HOLDER?

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.

REUSABLE LIMB HOLDER

K963473 · Deroyal Industries, Inc. · FMQ · Nov 14, 1996 · General Hospital

Device Facts

Record ID	K963473
Device Name	REUSABLE LIMB HOLDER
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. Reusable Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination or protection of the patient or others. The Reusable Limb Holder can be used with a gurney, bed, or stretcher.

Device Story

Reusable limb holder; protective restraint device. Limits patient limb movement to facilitate examination or ensure safety of patient/others. Used in clinical settings (beds, gurneys, stretchers). Operated by healthcare professionals. Construction: flannel/blue purr material, white webbing straps, nylon hook fasteners, steel nickel-plated buckles. Universal size. Requires physician prescription every 24 hours.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: flannel, blue purr, white webbing, nylon hook, steel nickel-plated buckles. Universal size. Mechanical restraint device; no energy source or software.

Indications for Use

Indicated for mildly to moderately agitated or disoriented patients requiring limb movement limitation for examination or protection, as prescribed by a licensed healthcare professional.

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

K963476 — DISPOSABLE LIMB HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
K963468 — RESTRICTIVE LIMB HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963466 — PEDIATRIC LIMB HOLDER · Deroyal Industries, Inc. · Feb 13, 1997
K963469 — MITTENS · Deroyal Industries, Inc. · Nov 14, 1996

Submission Summary (Full Text)

{0} NOV 14 1996 K963473 DeRoyal Industries, Inc. Reusable 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. Reusable Limb Holder COMMON/USUAL NAME: Reusable 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. Reusable Limb Holder is a protective restraint device that is intended for medical purposes to limit patient limb movements thereby enabling examination or protection of the patient or others. Device Design/Materials Used/Physical Properties: The DeRoyal Reusable Limb Holder is designed similar to those marketed by other manufacturers. The Reusable Limb Holder is primarily comprised of a flannel and/or blue purr material. The straps are made of white webbing. The fasteners include a nylon hook and steel nickel plated buckles. DEVICE INTENDED USE The DeRoyal Industries, Inc. Reusable Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination or protection of the patient or others. The Reusable 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 flannel and/or blue purr material. The straps are made of white webbing. Fasteners include nylon hook and steel nickel plated buckles. | 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 | Mildly to moderately agitated or disoriented | Same |