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

Indications for 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)

Submission Summary (Full Text)

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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: [phone]
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 |