MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT

K963393 · Depuy, Inc. · FMQ · Oct 31, 1996 · General Hospital

Device Facts

• Record ID: K963393
• Device Name: MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
• Applicant: Depuy, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Oct 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Intended Use

The DePuy Mesh Vest Restraint with Sleeves and the DePuy Wrist/Ankle Restraints are intended to be used as protective restraints to secure a patient to a chair, wheelchair, or bed.

Device Story

Protective restraints for patient immobilization; includes mesh vest with sleeves and wrist/ankle restraints. Vest constructed from polyester mesh; features hook and loop closures, waist ties, and straps for securing to furniture. Wrist/ankle restraints made of polyester pile fabric with knitted backing; secured via hook and loop; includes sliding metal or nylon acetal quick-release buckles. Used in clinical or home settings to secure patients to chairs, wheelchairs, or beds. Operated by healthcare providers or caregivers. Benefits include patient safety by limiting movement and preventing falls.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: polyester mesh fabric (vest), polyester pile fabric with knitted backing (wrist/ankle). Fasteners: hook and loop closures, sliding metal buckles, or nylon acetal quick-release buckles. Form factor: vest (five sizes, XS-XL), wrist/ankle restraints (universal adult size). Non-powered, manual operation.

Indications for Use

Indicated for patients requiring protective restraint to secure them to a chair, wheelchair, or bed to prevent movement or falls.

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. Vest Restraint
• J. T. Posey Co. Limb Holders

Submission Summary (Full Text)

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OCT 31 1996
K963393
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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NAME OF FIRM:
DePuy, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Registration No.: 1818910

FIRM CONTACT:
Arlene Saull, RAC
Manager, Medical Device Submissions

TRADE NAME:
DePuy Mesh Vest Restraint with Sleeves
DePuy Wrist/Ankle Restraint

COMMON NAME:
Protective Restraints

CLASSIFICATION:
Class I per 21 CFR, 880.6760 Protective Restraint

DEVICE PRODUCT CODE:
80 FMQ Restraint, Protective

SUBSTANTIALLY EQUIVALENT DEVICES:
J. T. Posey Co. Vest Restraint
J. T. Posey Co. Limb Holders

DEVICE DESCRIPTION AND INTENDED USE:

Vest Restraint:
The body of the vest restraint is constructed from two main pattern pieces, a front and a back which are cut from light weight polyester mesh fabric. The back is split down the center which results in there being two identical back pieces. The back opening facilitates the application of the garment to the patient. It contains a hook and loop closure which extends from the neck through to the bottom of the vest. The vest comes equipped with long straps attached just below waist level for securing the patient to the chair, wheelchair or bed; ties at the waist to adjust for proper fit; underarm loops to which the optional 54" long straps can be attached if additional support is required; and a modified v-neck. It is supplied in five sizes from X-small to X-large to fit chests from 28" to 56". It may be hand washed in warm water and air dried.

Wrist/Ankle Restraints:
The wrist/ankle restraints are simply constructed from a polyester pile fabric with a knitted backing. They are secured to the wrist or ankle with a hook and loop closure and are supplied with a long strap which is used to secure the wrist/ankle restraint to a chair, wheelchair or bed. The wrist/ankle restraints are available with two types of buckles on the long straps; sliding metal buckle or a white (nylon acetal) quick-release buckle. Both styles are provided in one universal adult size. They may be hand washed in warm water and air dried.

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M96 3.39.3
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## BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Mesh Vest Restraint with Sleeves and the DePuy Wrist/Ankle Restraints are substantially equivalent to protective restraints marketed by the J. T. Posey Co. based on their similarities in design, construction, materials, fasteners, and intended uses.

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