PROTECTIVE RESTRAINT - BELTS

K963490 · Smith and Nephew Donjoy, Inc. · FMQ · Nov 12, 1996 · General Hospital

Device Facts

• Record ID: K963490
• Device Name: PROTECTIVE RESTRAINT - BELTS
• 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

These devices are Universal Gait Belt, Wheelchair Belt, Foam Limb Restraint, Double Buckle Limb Restraint, Comfort Safety Belt, Comfort Slider Belt, Universal Roll Belt and belt style restraints used to restrain patients in a wheelchair or bed. The devices are labeled for prescription use and are not intended for lay use.

Device Story

Patient restraint system comprising Universal Gait Belt, Wheelchair Belt, Foam Limb Restraint, Double Buckle Limb Restraint, Comfort Safety Belt, Comfort Slider Belt, and Universal Roll Belt. Devices utilize straps for securing patients in wheelchairs or beds. Used in clinical settings by healthcare professionals. Polyester, cotton, nylon, and polyethylene construction in mesh or weave substrates. No electronic or algorithmic components.

Clinical Evidence

No clinical data; bench testing only based on historical commercial distribution and lack of adverse event reports.

Technological Characteristics

Materials: polyester, cotton, nylon, polyethylene. Configuration: mesh or weave substrate with securing straps. Non-electronic, mechanical restraint system.

Indications for Use

Indicated for patients requiring restraint in a wheelchair or bed. Prescription use only; not for lay use.

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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NOV-1-96 FRI 14:55 SMITH & NEPHEW DON. 2777 LOKAT AVENUE WEST
Cuthbert, CA 92008-6601 U.S.A.
Telephone: [phone]
Toll-free: [phone]
Telefax: [phone]

510(k) Summary
K 96-3490
NOV 12 1996

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

Smith & Nephew

K. SUMMARY OF SAFETY AND EFFECTIVENESS
These devices are Universal Gait Belt, Wheelchair Belt, Foam Limb Restraint, Double Buckle Limb Restraint, Comfort Safety Belt, Comfort Slider Belt, Universal Roll Belt and belt style restraints used to restrain patients in a wheelchair or bed. The devices are labeled for prescription use and are not intended for lay use. 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 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

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