POSEY STRAIGHT JACKETS

K963410 · J. T. Posey Co. · FMQ · Nov 22, 1996 · General Hospital

Device Facts

• Record ID: K963410
• Device Name: POSEY STRAIGHT JACKETS
• 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 limit movement in a hospital patient.

Device Story

Straight jackets; physical restraints; limit patient movement. Input: patient limbs (wrists, hands, ankles). Mechanism: fabric enclosure secured by straps with heavy-duty corset or standard buckles. Output: physical restriction of movement. Used in hospital settings; operated by clinical staff. Benefit: prevents patient self-injury or interference with medical treatment.

Clinical Evidence

No clinical data; bench testing only. Device relies on historical safety and effectiveness data from up to 20 years of commercial distribution.

Technological Characteristics

Fabric-based limb restraints; heavy-duty corset or standard buckle closure mechanisms. Mechanical design for physical immobilization.

Indications for Use

Indicated for hospital patients requiring movement limitation via wrist, hand, or ankle restraint.

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. Straight Jackets (legally marketed exempt devices)

Submission Summary (Full Text)

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NOV 22 1996
K963410
C
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: K963410

Trade Name: Straight Jackets
Common Name: Straight Jackets
Classification Name: Protective Restraints

The devices included in this 510(k) submission limit movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured around the patient via straps. These straps are secured behind the patient with either heavy duty corset buckles or heavy duty standard buckles.

These products are intended to limit movement in a hospital patient.

The devices used for comparative purposes are identical to the straight jackets 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 straight jackets 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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