HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP

K962834 · Heelbo, Inc. · FMQ · Oct 18, 1996 · General Hospital

Device Facts

• Record ID: K962834
• Device Name: HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP
• Applicant: Heelbo, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Oct 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Indications for Use

Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap, and Strap is intended to be a protective limb restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.

Device Story

Disposable quilted limb holder; secures to bed, gurney, chair, or wheelchair via straps, Velcro fastener, Double D-Ring, and quick-release snap. Used by caregivers to limit patient movement for treatment, examination, or protection. Allows wrist adjustment without cinching; supports supine and sitting positions. Machine washable. Provides physical restraint to prevent patient injury or interference with medical care.

Clinical Evidence

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

Technological Characteristics

Quilted limb holder; Velcro fastener; Double D-Ring; quick-release snap; straps. Available in two sizes (Small-Regular and Large-X-Large). Machine washable. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring protective limb restraint to limit movement for treatment, examination, or safety of the patient or others; applicable for use in supine or sitting positions.

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 Limb Holder with Double D-Ring, Quick-Release Snap and Strap

Submission Summary (Full Text)

{0}

Ke96 2834

Heelbo, Inc.

1134 N. Homan Ave. Chicago, IL 60651

312/489-7711

Telex RCA 297-248

800/323-5444

Fax [phone]

OCT 18 1996

Heelbo, Inc.

Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap

## 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 - July 17, 1996

2. Name of Device:

Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap

3. Name of Predicate Device

Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap

4. Description of Device

Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is a disposable quilted limb holder with a Velcro® fastener, Double D-Ring, Quick-Release Snap and Straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is intended to be a protective limb restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The Heelbo Quilted Limb Holder allows for wrist adjustment to provide a secure fit without cinching. The Double D-Ring is simple to use and allows the caregiver easy access to the patient. Also, the adjustable Double D-Ring and Quick-Release Snap allow for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.

The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is available in the following sizes:

| Stock No. 9350 | Stock No. 9360 |
| --- | --- |
| Small-Regular / cuff size: 11 ½" long
strap: 3/4" wide, 60" long | Large-X-Large / cuff size: 13 ½" long
strap: 3/4" wide, 60" long |

Page 18

{1}

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

Heelbo, Inc.
Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap

## 5. Statement of Intended Use

Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap, and Strap is intended to be a protective limb restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.

## 6. Statement of Technological Characteristics of the Device

Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is a disposable quilted limb holder with a Velcro® fastener, Double D-Ring, Quick-Release Snap and Straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is intended to be a protective limb restraint that limits the patient’s movement to the extent necessary for treatment, examination, or protection of the patient or others. The Heelbo Quilted Limb Holder allows for wrist adjustment to provide a secure fit without cinching. The Double D-Ring is simple to use and allows the caregiver easy access to the patient. Also, the adjustable Double D-Ring and Quick-Release Snap allow for supine and sitting positions.

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 [501(k)] Submissions for Protective Restraints” dated December 1995.

## 7. Biocompatibility Assessment

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.

## Conclusion

Based upon the information presented above it is concluded that the proposed Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap, and Strap is safe and effective for its intended use and is substantially equivalent to the predicate device.

Page 19