HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET

K963099 · Heelbo, Inc. · FMQ · Nov 1, 1996 · General Hospital

Device Facts

• Record ID: K963099
• Device Name: HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET
• Applicant: Heelbo, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho’s are also intended to limit the patient’s movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails.

Device Story

Poncho-style safety vests; used in clinical or home settings to secure patients in wheelchairs, geriatric chairs, or beds. Device features two or four straps for attachment to chair or bed frames; optional pocket for personal items. Available in poly/cotton blend or polyester mesh; machine washable. Acts as physical restraint to limit patient movement, prevent slumping/sliding, and mitigate fall risk. Operated by caregivers or clinical staff.

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 safety vests; materials: poly/cotton blend or polyester mesh; five sizes; machine washable; two or four-strap attachment system for wheelchair/bed frames.

Indications for Use

Indicated for patients requiring assistance to prevent slumping or sliding while seated in wheelchairs or geriatric chairs, or to limit movement and prevent falls or climbing over side rails while in bed.

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 Pullover Poncho and Pullover Poncho with Pocket (K963099)

Submission Summary (Full Text)

{0}

10/31/96 14:47 847 918 3860
004
K963099
NOV 1 1996

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

Heelbo, Inc.
Pullover Poncho and Pullover Poncho with Pocket

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 Pullover Poncho and Pullover Poncho with Pocket

3. Name of Predicate Device(s)
Heelbo Pullover Poncho and Pullover Poncho with Pocket

4. Description of Device
The Heelbo Pullover Poncho and Pullover Poncho with Pocket are poncho-style safety vests. The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails. The Heelbo Pullover Poncho has two straps that secure to the bed frame, wheelchair or geri-chair frame while the Pullover Poncho with Pocket has four straps that secure the bed frame, wheelchair or geri-chair frame. The Pullover Poncho with pocket provides the patient with a pocket to put personal items in.

Both Heelbo Poncho restraints are available in a poly/cotton blend or a polyester mesh material and are available in five sizes to accommodate a wide range of patients. Both styles of pullover poncho are machine washable for continued use.

The following chart shows product availability:

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10/31/96 14:48 847 918 3860
005

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

Heelbo, Inc.
Pullover Poncho and Pullover Poncho with Pocket

| Size of Vest | Material | Color |
| --- | --- | --- |
| x-small | Poly/Cotton blend | White |
| small | Poly/Cotton blend | Yellow |
| medium | Poly/Cotton blend | Blue |
| large | Poly/Cotton blend | Green |
| x-large | Poly/Cotton blend | Beige |
| x-small | Polyester Mesh | White bias on white breezewear |
| small | Polyester Mesh | Yellow bias on white breezewear |
| medium | Polyester Mesh | Blue bias on white breezewear |
| large | Polyester Mesh | Green bias on white breezewear |
| x-large | Polyester Mesh | Beige bias on white breezewear |

5. Statement of Intended Use
The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho’s are also intended to limit the patient’s movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails.

6. Statement of Technological Characteristics of the Device
The Heelbo Pullover Poncho and Pullover Poncho with Pocket are poncho-style safety vests. The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho’s are also intended to limit the patient’s movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails. The Heelbo Pullover Poncho has two straps that secure to the bed frame, wheelchair or geri-chair frame while the Pullover Poncho with Pocket has four straps that secure the bed frame, wheelchair or geri-chair frame. The Pullover Poncho with pocket provides the patient with a pocket to put personal items in.

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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10/31/96 14:49 847 210 000.
006

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

Heelbo, Inc.
Pullover Poncho and Pullover Poncho with Pocket

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 Pullover Poncho and Pullover Poncho with Pocket are safe and effective for their intended use and are substantially equivalent to the predicate devices.