PROTECTIVE RESTRAINT (WAIST HOLDER)

K963421 · Kenad SG Medical, Inc. · FMQ · Nov 22, 1996 · General Hospital

Device Facts

• Record ID: K963421
• Device Name: PROTECTIVE RESTRAINT (WAIST HOLDER)
• 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: Pediatric

Intended Use

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

Device Story

Waist Holder is a protective restraint device used to limit patient movement. It consists of a polyurethane foam belt, flexible polypropylene side straps, and a plastic quick-release buckle. The device is applied around the patient's waist; side straps are secured via quick-release buckles to anchor straps attached to an immovable object, such as a bed or chair. Operated by healthcare staff in clinical settings, the device restricts patient mobility to facilitate treatment or ensure safety. Benefit is derived from controlled patient positioning and protection.

Clinical Evidence

No clinical trials were conducted. Evidence is based on 5 years of post-market performance data, including over 10,000 product uses with zero reported patient injuries or product failure complaints.

Technological Characteristics

Materials: blue polyurethane foam (belt), flexible polypropylene (side straps), plastic (quick-release buckle). Form factor: wearable belt with adjustable straps for bed or chair anchoring. Mechanical restraint principle. No energy source or software components.

Indications for Use

Indicated for adults and children requiring limited movement for medical treatment, examination, or protection of the patient or others.

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

• Waist Holder (Danek Medical, Inc., K823815)

Submission Summary (Full Text)

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K963421
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 thru August 1996.

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

As noted in the Cover Letter, four 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

Waist Holder is the trade or proprietary name for the devices which are the subject of this Premarket Notification Submission. Within this name are four Kenad Waist Holders.

| KENAD Catalog # | Size |
| --- | --- |
| 50-3400 | Pediatric |
| 50-3500 | Adult |
| 50-3600 | Adult Universal w/Slit |
| 50-3700 | Adult X-Wide |

### 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 Waist Holder subject to this Premarket Notification Submission is comparable to Waist Holder from Danek Medical, Inc. Danek successfully filed a Premarket notification for waist holders at Document Control number K823815, January 17, 1983.

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

4.1. General Description

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

| Belt- | Blue, polyurethane foam |
| --- | --- |
| Side Strap- | Flexible, polypropylene |
| Quick Release Buckle- | Plastic buckle |
| Anchor Strap- | Flexible, polypropylene |

4.2. How Waist Holder Functions

Waist Holders are placed comfortably around the waist as a belt. The Side Straps are then affixed by Quick Disconnect to an Anchor Strap affixed to an immovable object either on a bed, for bed application, or on a chair, for chair application.

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

5.1. Indications

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

5.2. Patient Population

Kenad Waist Holders are used with adults and children.

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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 Waist Holders are comparable to Waist Holders from Danek Medical, Inc. A comparison of these devices are provided in this Premarket Notification Submission.

7. PERFORMANCE DATA (807.92(b))

More than 10,000 Kenad Waist Holders were sold over the last 5 years. Assuming 100% usage, there have been more than 10,000 patient contacts with Waist Holders over the last 5 years. During this time, Kenad received no patient injury or product failure complaints about the Waist Holders.

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

The absence of patient injury or product failure complaints following more than 10,000 product uses over 5 years indicates the Kenad Waist Holders are safe and effective.

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