HEELBO LIFE JACKET WITH CROTCH SUPPORT

K963041 · Heelbo, Inc. · FMQ · Oct 31, 1996 · General Hospital

Device Facts

• Record ID: K963041
• Device Name: HEELBO LIFE JACKET WITH CROTCH SUPPORT
• Applicant: Heelbo, 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 Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.

Device Story

Poncho-style safety vest with padded crotch support; features three sets of two straps for secure attachment to wheelchair or geriatric chair components. Supports upper torso to maintain patient posture. Used in clinical or home settings to prevent patient slumping or sliding. No electronic or automated components.

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

Poncho-style vest; materials include polyester/cotton blend or polyester mesh. Mechanical restraint system using straps for wheelchair/geriatric chair attachment. Non-powered, manual device.

Indications for Use

Indicated for patients seated in wheelchairs or geriatric chairs who require support to prevent slumping or sliding forward.

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 Life Jacket with Crotch Support

Submission Summary (Full Text)

{0}

10/30/96 14:56 847 918 3860 003

Heelbo, Inc.
1134 N. Homan Ave.
Chicago, IL 60651
312/489-7711
Telex RCA 297-248
800/323-5444
Fax [phone]
OCT 31 1996
K963041

Heelbo, Inc.
Life Jacket with Crotch Support

510(k) Summary

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

| Submitter | Contact Person |
| --- | --- |
| Heelbo, Inc. | Joseph S. Tokarz, Manager, Regulatory Affairs |
| 1134 N. Homan | Hollister Incorporated |
| Chicago, IL 60651 | 2000 Hollister Drive
Libertyville, IL 60048
Ph [phone], Fax [phone] |

Date Summary Prepared - October 30, 1996

2. Name of Device:
Heelbo Life Jacket with Crotch Support

3. Name of Predicate Device(s)
Heelbo Life Jacket with Crotch Support

4. Description of Device
The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.

The Life Jacket with Crotch Support is available in a polyester and cotton blend (9400) or a polyester mesh material (9400B). The following chart shows product availability:

| Stock Number | Size of Vest | Color |
| --- | --- | --- |
| 9400 | x-small | White |
| 9400 | small | Yellow |
| 9400 | medium | Blue |
| 9400 | large | Green |
| 9400 | x-large | Beige |
| 9400B | x-small | White bias on white breezewear |
| 9400B | small | Yellow bias on white breezewear |
| 9400B | medium | Blue bias on white breezewear |
| 9400B | large | Green bias on white breezewear |
| 9400B | x-large | Beige bias on white breezewear |

{1}

10/30/96 14:56 847 918 3860
004

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

Heelbo, Inc.
Life Jacket with Crotch Support

5. Statement of Intended Use
The Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.

6. Statement of Technological Characteristics of the Device
The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.

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 Life Jacket with Crotch Support is safe and effective for it's intended use and is substantially equivalent to the predicate device.