Who is the manufacturer of DISPOSABLE LIMB HOLDER?

Deroyal Industries, Inc. submitted the Traditional clearance for DISPOSABLE LIMB HOLDER (K963476).

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

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

What are the predicate devices for DISPOSABLE LIMB HOLDER?

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

DISPOSABLE LIMB HOLDER

K963476 · Deroyal Industries, Inc. · FMQ · Jan 22, 1997 · General Hospital

Device Facts

Record ID	K963476
Device Name	DISPOSABLE 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. Disposable 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 Disposable Limb Holder can be used with a gurney, bed, or stretcher.

Device Story

Disposable limb holder; protective restraint device. Limits limb movement to facilitate examination or ensure safety of patient/others. Used in clinical settings (beds, gurneys, stretchers). Operated by healthcare professionals. Constructed from kodel, nylon, flannel, or blue purr material; white webbing straps; hook and loop or steel nickel-plated buckle fasteners. Universal size. Prescribed by physician every 24 hours.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: kodel, nylon, flannel, blue purr; white webbing straps. Fasteners: hook and loop or steel nickel-plated buckles. Universal size. Non-powered, mechanical restraint device.

Indications for Use

Indicated for mildly to moderately agitated or disoriented patients requiring limb movement limitation for examination or protection of patient/others; use 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

K963473 — REUSABLE LIMB HOLDER · Deroyal Industries, Inc. · Nov 14, 1996
K963466 — PEDIATRIC LIMB HOLDER · Deroyal Industries, Inc. · Feb 13, 1997
K963468 — RESTRICTIVE LIMB HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963465 — PELVIC HOLDER · Deroyal Industries, Inc. · Dec 19, 1996

Submission Summary (Full Text)

{0} DeRoyal Industries, Inc. Disposable Limb Holder 510(k) Summary K 9634 76 JAN 22 1997 # 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. Disposable Limb Holder COMMON/USUAL NAME: Disposable 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. Disposable 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 Disposable Limb Holder is designed similar to those marketed by other manufacturers. The Disposable Limb Holder is primarily comprised of a kodel, nylon, flannel or blue purr material. The straps are made of white webbing. The fasteners are made of hook and loop or steel nickel plated buckles. ## DEVICE INTENDED USE The DeRoyal Industries, Inc. Disposable 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 Disposable 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 kodel, nylon, flannel or blue purr material. The straps are made of white webbing. Fasteners include hook and loop or 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 |