Who is the manufacturer of PELVIC HOLDER?

Deroyal Industries, Inc. submitted the Traditional clearance for PELVIC HOLDER (K963465).

What is the FDA product code for PELVIC 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 PELVIC HOLDER?

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

What are the predicate devices for PELVIC HOLDER?

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

PELVIC HOLDER

K963465 · Deroyal Industries, Inc. · FMQ · Dec 19, 1996 · General Hospital

Device Facts

Record ID	K963465
Device Name	PELVIC HOLDER
Applicant	Deroyal Industries, Inc.
Product Code	FMQ · General Hospital
Decision Date	Dec 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1

Intended Use

The DeRoyal Industries, Inc. Pelvic Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movement thereby enabling examination or protection of the patient or others. The Pelvic Holder is a protective restraint which can be used with a bed or wheelchair.

Device Story

Pelvic holder; protective restraint device. Limits patient movement to facilitate examination or ensure safety of patient/others. Used in clinical settings (beds or wheelchairs). Operated by healthcare professionals. Comprised of cotton cloth, flannel, cool knit, or cotton sheeting. Available in disposable or extra security styles. Prescribed by physician every 24 hours.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: cotton cloth, flannel, cool knit, or cotton sheeting. Form factor: pelvic restraint strap. Attachment: bed or wheelchair. Styles: disposable or extra security.

Indications for Use

Indicated for mildly agitated or disoriented patients with a tendency to leave bed or wheelchair, requiring movement limitation for examination or safety, 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

K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963467 — ROLL BELTS · Deroyal Industries, Inc. · Jan 3, 1997
K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
K963474 — TUXEDO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963476 — DISPOSABLE LIMB HOLDER · Deroyal Industries, Inc. · Jan 22, 1997

Submission Summary (Full Text)

{0} DEC 19 1996 DeRoyal Industries, Inc. Pelvic 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. Pelvic Holder COMMON/USUAL NAME: Pelvic 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. Pelvic Holder is a protective restraint device that is intended for medical purposes to limit patient movement thereby enabling examination or protection of the patient or others. **Device Design/Materials Used/Physical Properties**: The DeRoyal Pelvic Holder is designed similar to those marketed by other manufacturers. The Pelvic Holder is primarily comprised of either cotton cloth, flannel, cool knit, or cotton sheeting. DEVICE INTENDED USE The DeRoyal Industries, Inc. Pelvic Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movement thereby enabling examination or protection of the patient or others. The Pelvic Holder is a protective restraint which can be used with a bed or wheelchair. TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | The body is comprised of either cotton cloth, flannel, cool knit, or cotton sheeting | Same | | Style Variations | Disposable or Extra Security | Same | | Vehicles for Attachment | Bed or Wheelchair | Same | | Length of use | Doctor must prescribe every 24 hours | Same | | Level of Patient Activity | Mildly Agitated or Disoriented Tendency to Leave Bed or Wheelchair | Same |