HEELBO JOHNNY GRAIT BELT SECURITY BELT

K962964 · Hollister, Inc. · FMQ · Oct 24, 1996 · General Hospital

Device Facts

• Record ID: K962964
• Device Name: HEELBO JOHNNY GRAIT BELT SECURITY BELT
• Applicant: Hollister, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Oct 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Intended Use

The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney.

Device Story

Security belt for patient restraint; cotton construction with polypropylene quick-release buckle and D-ring Velcro loop fasteners. Dimensions: 2 inches wide, 60 inches long. Used in clinical settings (hospitals, nursing homes) to secure patients to wheelchairs, geri-chairs, commodes, beds, or gurneys. Operated by healthcare staff to prevent patient falls or unauthorized movement. Provides physical restraint to enhance patient safety.

Clinical Evidence

No clinical data. Biocompatibility assessment based on history of safe use of materials in the clothing and garment industry and absence of reported skin irritation.

Technological Characteristics

Materials: cotton belt, polypropylene quick-release snap buckle, D-ring Velcro loop fasteners. Dimensions: 2 inches wide by 60 inches long. Mechanical restraint device; no energy source, software, or electronic components.

Indications for Use

Indicated for patients requiring securement while seated in wheelchairs, geri-chairs, or chair commodes, or while lying on beds or gurneys.

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

• Heelbo Johnny Grait Belt Security Belt (K962964)

Submission Summary (Full Text)

{0}

Heelbo, Inc.
1134 N. Homan Ave.
Chicago, IL 60651
312/489-7711
Telex RCA 297-248
800/323-5444
Fax [phone]
K962964

OCT 24 1996

Heelbo, Inc.
Johnny Grait Belt Security Belt

## 510(k) Summary

### 1. Submitter's name, Address and Contact Person

| Submitter | Contact Person |
| --- | --- |
| Heelbo, Inc.
1134 N. Homan
Chicago, IL | Joseph S. Tokarz, Manager, Regulatory Affairs
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048
Ph [phone], Fax [phone] |

Date Summary Prepared - October 22, 1996

### 2. Name of Device:
Heelbo Johnny Grait Belt Security Belt

### 3. Name of Predicate Device(s)
Heelbo Johnny Grait Belt Security Belt

### 4. Description of Device
The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chairs, chair commodes, wheelchairs, beds and gurneys.

The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney.

### 5. Statement of Intended Use
The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney.

{1}

Heelbo, Inc.
1134 N. Homan Ave.
Chicago, IL 60651
312/489-7711
Telex RCA 297-248
800/323-5444
Fax [phone]

Heelbo, Inc.
Johnny Grait Belt Security Belt

6. Statement of Technological Characteristics of the Device

The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chairs, chair commodes, wheelchairs, beds and gurneys.

The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification. The only difference is that the product labeling has been revised to comply with the Agency's labeling requirements set forth in the draft Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints dated December 1995.

7. Biocompatibility Assessment

The subject devices are identical in components materials to the predicate devices. The suppliers of the materials used in the fabrication of these devices have stated that there is a history of safe use of their materials in the clothing and garment industry. In addition, Heelbo, Inc., is not aware of any reports or complaints of skin irritation associated with these materials.

8. Conclusion

Based upon the information presented above it is concluded that the proposed Heelbo Johnny Grait Belt Security Belt is safe and effective for it's intended use and is substantially equivalent to the predicate device.