PEDIATRIC LIMB HOLDERS

K963439 · J. T. Posey Co. · FMQ · Nov 19, 1996 · General Hospital

Device Facts

• Record ID: K963439
• Device Name: PEDIATRIC LIMB HOLDERS
• Applicant: J. T. Posey Co.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Pediatric limb holders; designed to limit limb/finger movement; device encircles wrists, hands, or ankles; secured to hospital bed or crib via straps using quick-release knots or safety pins; used in clinical settings; operated by healthcare staff; prevents patient self-injury or interference with medical treatment.

Clinical Evidence

No clinical data; bench testing only based on historical performance and established market presence.

Technological Characteristics

Limb restraint system; fabric/strap construction; mechanical securement via straps and quick-release knots or safety pins; non-powered; manual operation.

Indications for Use

Indicated for pediatric patients requiring limitation of limb or finger movement while in a hospital bed or crib.

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. pediatric limb holders (legally marketed/exempt status)

Submission Summary (Full Text)

{0}

NOV-18-1996 12:38
J. T. Posey Co.
818 443 5064 P.10/11
K963439
Customer Service
Toll Free: (800) 44-POSEY
Tel: [phone]
Fax: [phone]

# PAYROLL
# CONSULATE

# Posey Company
5635 Peck Road • Arcadia, California 91006-0020 U.S.A.

# SAFETY AND EFFECTIVENESS SUMMARY
NOV 19 1996

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: K963439

Trade Name: Protective Restraints
Common Name: Pediatric 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 hospital bed or crib via straps. These straps are securely connected to the hospital bed or crib by quick release knots or with the use of a safety pin.

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

The devices used for comparative purposes are identical to the pediatric 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) Premarket 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 pediatric 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.

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