MULTIPLE BELTS

K963414 · J. T. Posey Co. · FMQ · Nov 22, 1996 · General Hospital

Device Facts

• Record ID: K963414
• Device Name: MULTIPLE BELTS
• Applicant: J. T. Posey Co.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Intended Use

These products are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, geriatric chair, or gurney.

Device Story

Protective restraints; waist/torso support belts; secure patient to bed, geriatric chair, wheelchair, or gurney via straps. Straps secured using knots, double D rings, hook and loop, standard buckles, or quick-release hardware. Used in clinical/long-term care settings to hinder egress or aid positioning. Operated by healthcare staff. Benefit: patient safety through fall prevention and positioning stability.

Clinical Evidence

No clinical data; bench testing only. Devices have been in commercial distribution for up to 20 years.

Technological Characteristics

Waist/torso support belts; strap-based securement system using knots, double D rings, hook and loop, or buckles. Mechanical restraint design; no energy source or software.

Indications for Use

Indicated for patients requiring assistance with positioning or egress prevention while in a wheelchair, hospital bed, geriatric chair, or gurney.

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 Co. Protective Restraints (legally marketed devices per FDA guidance)

Submission Summary (Full Text)

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NOV 22 1996
K963444
Custody
Posey Company
5635 Peck Road • Arcadia, California 91006-0020 U.S.A.
Customer Service
Toll Free: (800) 44-POSEY
Tel: [phone]
Fax: [phone]

# SAFETY AND EFFECTIVENESS SUMMARY

JT Posey Company
5635 Peck Road
Arcadia, CA 91006
Michael Keefe
General Manager
August 30, 1996
Revised: November 18, 1996

Phone # [phone]
FAX # [phone]
Reference Number: K963414

Trade Name: Protective Restraints
Common Name: Belts
Classification Name: Protective Restraints

The devices included in this 510(k) submission support the waist or torso area. The product is closed around the patient by encircling the hips, legs or chest. The product is secured to the bed, geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, double D rings, hook and loop, standard buckles, or quick release buckles or hardware (screws).

These products are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, geriatric chair, or gurney.

The devices used for comparative purposes are identical to the belts as described in this submission and produced or sold by the J.T. Posey Co. This premarket submission is submitted in response to the agency's final rule published on March 4, 1996 in the Federal Register 21 CFR 880 and 21 CFR 890 Medical Devices, Protective Restraints - Revocation of Exemptions from 510(k) Pre-market Notification Procedures and Current Good Manufacturing Practice Regulation. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for comparison:

"Predicate device

FDA indicated that it would be appropriate for manufacturers to reference their current products as legally marketed devices for comparison purposes in their submissions. It would also be appropriate to reference any approved 510(k)s that manufacturers have submitted for their products."

The belts are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission, August 30, 1996. The limb holders have been manufactured and in commercial distribution for up to 20 years.

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