MULTIPLE LIMB HOLDERS

K963413 · J. T. Posey Co. · FMQ · Nov 14, 1996 · General Hospital

Device Facts

• Record ID: K963413
• Device Name: MULTIPLE LIMB HOLDERS
• Applicant: J. T. Posey Co.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Intended Use

These products are intended to limit limb movement or finger movement in a hospital bed or gurney.

Device Story

Protective restraints (limb holders) designed to limit patient limb/finger movement; device encircles wrists, hands, or ankles; secured to bed, gurney, geriatric chair, or wheelchair via straps; attachment mechanisms include knots, corset buckles, keyed lock buckles, square rings, hook and loop, standard buckles, or quick release buckles; used in clinical settings (hospitals) to prevent patient injury or interference with medical treatment; operated by healthcare staff; provides physical restriction to maintain patient safety.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical restraint devices; materials include fabric/straps with various fastening hardware (knots, buckles, hook and loop); non-powered; no software or electronic components.

Indications for Use

Indicated for patients requiring limitation of limb or finger movement while in a hospital bed, gurney, geriatric chair, or wheelchair.

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. Limb Holders (legally marketed devices per FDA guidance for K963413)

Submission Summary (Full Text)

{0}

NOV-13-1996 15:20 T. T. Posey Co. 818 443 5064 P.03/03

K963413
Customer Service
Toll Free: (800) 44-POSEY
Tel: [phone]
Fax: [phone]

# SAFETY AND EFFECTIVENESS SUMMARY

NOV 14 1996

JT Posey Company
5635 Peck Road
Arcadia, CA 91006
Michael Keefe
General Manager
August 30, 1996
Revised: November 13, 1996

Phone # [phone]
FAX # [phone]
Reference Number: K963413

Trade Name: Protective Restraints
Common Name: Limb Holders
Classification Name: Protective Restraints

The devices included in this 510(k) submission limit limb movement and/or finger movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured to the bed or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, corset buckles, keyed lock buckles, square rings, hook and loop, standard buckles, or quick release buckles.

These products are intended to limit limb movement or finger movement in a hospital bed or gurney.

The devices used for comparative purposes are identical to the limb holders 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 limb holders 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.

Manufacturers and worldwide distributors of quality healthcare products since 1937
TOTAL P.03