HEELBO QUILTED TORSO RESTRAINT

K963108 · Hollister, Inc. · FMQ · Oct 9, 1996 · General Hospital

Device Facts

• Record ID: K963108
• Device Name: HEELBO QUILTED TORSO RESTRAINT
• Applicant: Hollister, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Oct 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Intended Use

The Heelbo Quilted Torso Restraint is intended to help secure a patient at the torso or legs while lying on a bed or gurney.

Device Story

Reinforced, padded belt (4.5" x 33.33") with polyester webbed strapping; wraps around bed/gurney frame; secures via drop-jaw buckle. Used in clinical settings to restrain patient torso or legs. Prevents patient movement; enhances safety during care. Operated by healthcare staff.

Clinical Evidence

No clinical data. Bench testing only; biocompatibility supported by history of safe use in clothing/garment industry and lack of reported skin irritation.

Technological Characteristics

Reinforced padded belt; polyester webbed strapping; drop-jaw buckle mechanism. Dimensions: 4.5 inches wide by 33.33 inches long.

Indications for Use

Indicated for patients requiring torso or leg securement while positioned on a bed or gurney.

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 Quilted Torso Restraint (K965108)

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]
K965108
OCT - 9 1996

Heelbo, Inc.
Quilted Torso Restraint

# Safety and Effectiveness Summary

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

| Submitter | Contact Person |
| --- | --- |
| Heelbo, Inc.
1134 N. Homan Ave.
Chicago, IL 60651 | Joseph S. Tokarz; Manager, Regulatory Affairs
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048
Ph: [phone], Fax: [phone] |
| Date Summary Prepared - August 8, 1996 | |

## 2. Name of Device:
Heelbo Quilted Torso Restraint

## 3. Name of Predicate Device(s)
Heelbo Quilted Torso Restraint

## 4. Description of Device
The Heelbo Quilted Torso Restraint is a reinforced, padded belt 4½ inches wide by 33⅓ inches long. The Quilted Torso Restraint is designed with polyester webbed strapping that is wrapped around the frame of a bed or gurney and threaded through a drop-jaw buckle to secure the patient at the torso or legs.

## 5. Statement of Intended Use
The Heelbo Quilted Torso Restraint is intended to help secure a patient at the torso or legs while lying on a bed or gurney.

## 6. Statement of Technological Characteristics of the Device
The Heelbo Quilted Torso Restraint is a reinforced, padded belt 4½ inches wide by 33⅓ inches long. The Quilted Torso Restraint is designed with polyester webbed strapping that is wrapped around the frame of a bed or gurney and threaded through a drop-jaw buckle to secure the patient at the torso or legs.

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

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{1}

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

Heelbo, Inc.
Quilted Torso Restraint

forth in the draft “Guidance on the Content of Premarket Notification [501(k)] Submissions for Protective Restraints” dated December 1995.

## 7. Biocompatibility

The subject devices are identical in component materials to the predicate devices. The suppliers of the materials use 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 Quilted Torso Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.

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