PROTECTIVE RESTRAINT (VEST RESTRAINT)

K963430 · Kenad SG Medical, Inc. · FMQ · Nov 22, 1996 · General Hospital

Device Facts

• Record ID: K963430
• Device Name: PROTECTIVE RESTRAINT (VEST RESTRAINT)
• Applicant: Kenad SG Medical, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

Kenad Vest Restraints are indicated for medical purposes where patient movement must be limited to the extent necessary for treatment, examination, protection of the patient or others, or posture control.

Device Story

Vest Restraint is a wearable jacket-style device used to limit patient movement. It is placed around the upper body and secured via side straps, a quick-release buckle, and an anchor strap attached to a stationary bed or chair. Operated by healthcare staff in clinical settings, the device restricts mobility to facilitate medical treatment, examinations, or posture control. It serves as a protective measure for the patient or others. The device is available in multiple sizes and configurations, including versions with or without sleeves and tails.

Clinical Evidence

No clinical trials performed. Safety and efficacy are supported by post-market performance data: over 5,000 units sold and used over a 5-year period with zero reports of patient injury or product failure.

Technological Characteristics

Materials: flame-retardant polyester cotton twill fabric (vest), nickel-plated polished metal (shoulder ring), polypropylene (side and anchor straps), and plastic (quick-release buckle). Form factor: jacket-style restraint available in sizes X-Small through XX-Large.

Indications for Use

Indicated for adults and children requiring movement limitation for treatment, examination, patient/staff protection, or posture control.

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

• Danek Medical, Inc. Vest Restraints (K823815)

Submission Summary (Full Text)

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K963430
NOV 22 1996

# 510(k) SUMMARY

## 1. PERSONNEL AND DATE (807.92(a)(1))

### 1.1. Submitter
Kenad SG Medical Inc.
2692 Huntley
Memphis, TN 38132

### 1.2. Contact Person
Kenneth Elmore
President and CEO
Kenad SG Medical Inc.

### 1.3. Date Of summary Preparation
This summary was prepared in July 1996.

## 2. DEVICE NAME (807.92(a)(2))

As noted in the Cover Letter, three similar devices are grouped within this 510(k) notification. These devices differ only in minor design aspects. Their function, application and use is identical.

### 2.1. Trade Or Proprietary Name
Vest Restraint is the trade or proprietary name for the devices subject to this Premarket Notification Submission. Within this name are the following:

- Pediatric Patient Protective Vest (Without Sleeves)
- Patient Protective Vest (Without Sleeves)
- Patient Protective Vest (With Sleeves)
- Patient Protective Vest (With Sleeves With Tails)

These devices are available in sizes: X-Small, Small, Medium, Large, X-Large and XX-Large.

### 2.2. Common Or Usual Name
Protective Restraint 21CFR 880.6760

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3. LEGALLY MARKETED DEVICE (807.92(a)(3))

The Kenad Vest Restraints subject to this Premarket Notification Submission are comparable to Vest Restraints from Danek Medical, Inc. Danek successfully filed a Premarket notification for their Vest Restraints at Document Control number K823815, January 17, 1983.

4. DEVICE DESCRIPTION (807.92(a)(4))

4.1. General Description

The Kenad Vest Restraints subject to this Premarket Notification are devices that comprise the following modules, cited in this document

Vest- blue, flame retardant polyester cotton twill fabric.
Shoulder Ring- nickle plated, polished metal buckle.
Side Strap- flexible, polypropylene material.
Quick Release Buckle- plastic buckle.
Anchor Strap- flexible, polypropylene material.

4.2. How Vest Restraints Function

Vest Restraints are placed about the upper body as a jacket. The jacket is fixed comfortably, yet snugly in place by crossing the side straps. The restraint is then affixed to a stationary part of a bed or chair via the Side Strap, Quick Release Buckle and Anchor Strap.

5. INTENDED USE (807.92(a)(5))

5.1. Indications

Kenad Vest Restraints are indicated for medical purposes where patient movement must be limited to the extent necessary for treatment, examination, protection of the patient or others, or posture control.

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## 5.2. Patient Population

Kenad Vest Restraints are used with adults and children.

## 5.3. Indications Different From Substantially Equivalent Device

Indications and patient populations for the Kenad devices are identical to the legally marketed device cited in this document.

## 6. COMPARISON TO LEGALLY MARKETED DEVICE (807.92(a)(6))

Kenad Vest Restraints are comparable to vest restraints from Danek Medical, Inc. A comparison of these devices are provided in this Premarket Notification Submission.

## 7. PERFORMANCE DATA (807.92(b))

More than 5000 Kenad Vest Restraints were sold over the last 5 years. Assuming 100% usage, there have been more than 5000 patient contacts with Vest Restraints over the last 5 years. During this time, Kenad received no patient injury or product failure complaints about Vest Restraints.

## 8. SAFETY, EFFICACY AND PERFORMANCE CONCLUSION (807.92(b)(3))

The absence of patient injury or product failure complaints following approximately 5000 product uses over 5 years indicates Kenad Vest Restraints are safe and effective.

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