PROTECTIVE RESTRAINT

K963492 · Smith and Nephew Donjoy, Inc. · FMQ · Nov 12, 1996 · General Hospital

Device Facts

• Record ID: K963492
• Device Name: PROTECTIVE RESTRAINT
• Applicant: Smith and Nephew Donjoy, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Indications for Use

The Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest and Hand Control Mitt are intended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use. These devices are vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed.

Device Story

Vest, jacket, and mitt style restraints; used to secure patients in wheelchairs or beds; constructed from polyester, cotton, nylon, and polyethylene mesh or weave substrates; utilizes straps for tie-down; intended for cooperative patients requiring minimal support; prescription use only; clinical setting; prevents patient falls/injury.

Clinical Evidence

No clinical data; safety established via 60+ years of commercial distribution history without associated MDR complaints.

Technological Characteristics

Materials: polyester, cotton, nylon, polyethylene; configuration: mesh or weave substrate; mechanism: strap-based tie restraint; form factor: vest, jacket, and mitt styles.

Indications for Use

Indicated for cooperative patients requiring minimum support in a wheelchair or bed to prevent falls or injury. Not for lay use; prescription only.

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.

Submission Summary (Full Text)

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NO. 10-3-96
K963492

510k Summary

K96-3492

NOV 12 1996

Smith & Nephew DonJoy Inc.
2777 Laker Avenue West
Carlsbad, CA 92008-6601 U.S.A.
Telephone: [phone]
Toll-free: [phone]
Telefax: [phone]

Smith & Nephew

## X. SUMMARY OF SAFETY AND EFFECTIVENESS

The Economy Restraint, Jacket Restraint, Two Piece Vest Restraint, Safety Vest and Hand Control Mitt are intended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use. These devices are vest, jacket and mitt style restraints used to restrain patients in a wheelchair or bed. These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place. These devices have been commercially distributed for over four+60 years and have not been associated with an MDR type complaint.

Smith & Nephew DonJoy, Inc.

Dan W. Miller
Director of Regulatory Affairs and
Quality Assurance

BUNJAY.
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