HEELBO SECURITY BELT

K963060 · Heelbo, Inc. · FMQ · Nov 4, 1996 · General Hospital

Device Facts

• Record ID: K963060
• Device Name: HEELBO SECURITY BELT
• Applicant: Heelbo, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Intended Use

The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair.

Device Story

Padded belt (4.75" x 22") with cotton webbed straps; straps tie to wheelchair or geriatric chair frame; used to secure patient in seated position; prevents patient from sliding or falling; operated by caregivers in clinical or home settings.

Clinical Evidence

Bench testing only; no clinical data presented. Biocompatibility assessment based on history of safe use of materials in clothing/garment industry and lack of reported skin irritation.

Technological Characteristics

Padded belt, 4.75 inches wide by 22 inches long; cotton webbed straps; non-powered; mechanical restraint.

Indications for Use

Indicated for patients requiring assistance to remain secured while seated in a wheelchair or geriatric chair.

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 Security Belt

Submission Summary (Full Text)

{0}

11/01/96 12:46 847 918 3860
010/011

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

K963060

Heelbo, Inc.
Security Belt

510(k) Summary

1. Submitter's name, Address and Contact Person
Submitter: Heelbo, Inc.
1134 N. Homan
Chicago, IL 60651

Contact Person: Joseph S. Tokarz, Manager, Regulatory Affairs
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048
Ph [phone], Fax [phone]

Date Summary Prepared - November 1, 1996

2. Name of Device:
Heelbo Security Belt

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

4. Description of Device
The Heelbo Security Belt is a padded belt 4¾ inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.

5. Statement of Intended Use
The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair.

6. Statement of Technological Characteristics of the Device
The Heelbo Security Belt is a padded belt 4¾ inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.

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.

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{1}

11/01/96 12:47 847 918 3860

011/011

Heelbo, Inc.
1134 N. Homan Ave.
Chicago, IL 60651
312/489-7711

Telex RCA 297-248
800/323-5444
Fax [phone]

Heelbo, Inc.
Security Belt

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 Security Belt is safe and effective for its intended use and is substantially equivalent to the predicate device.

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