JACKETS AND VESTS

K963442 · J. T. Posey Co. · FMQ · Nov 22, 1996 · General Hospital

Device Facts

• Record ID: K963442
• Device Name: JACKETS AND VESTS
• 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
• Attributes: Therapeutic

Intended Use

These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, geriatric chair, wheelchair, or gurney.

Device Story

Protective restraints (jackets/vests) support patient torso; secure to hospital bed, geriatric chair, wheelchair, or gurney. Closure mechanisms include criss-cross fabric/straps, zippers, hook and loop, or tie strings. Attachment to furniture via straps using knots, double D rings, hook and loop, standard buckles, or quick-release buckles. Used in clinical settings to hinder patient egress or assist body alignment. Operated by healthcare staff.

Clinical Evidence

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

Technological Characteristics

Fabric-based torso restraints; closure via zippers, hook and loop, tie strings, or straps. Attachment via knots, double D rings, or buckles. Mechanical design only; no electronics or software.

Indications for Use

Indicated for patients requiring torso support or restraint to prevent egress or maintain body alignment while in a hospital bed, geriatric chair, wheelchair, 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 exempt devices)

Submission Summary (Full Text)

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NOV 22 1996

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

K963442

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: K963442

Trade Name: Protective Restraints
Common Name: Jackets and Vests
Classification Name: Protective Restraints

The devices included in this 510(k) submission support the torso area. The product is closed around the patient by one or more of the following: criss crossing the fabric and straps, a zipper, hook and loop, or tie strings. The product is secured to the bed, geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, wheelchair by one or more of the following: knots, double D rings, hook and loop, standard buckles, or quick release buckles.

These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, geriatric chair, wheelchair, or gurney.

The devices used for comparative purposes are identical to the jackets and vests 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 jackets and vests 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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