CHECKMATE ANKLE RESTRAINT SYSTEM

K962963 · Hollister, Inc. · FMQ · Oct 24, 1996 · General Hospital

Device Facts

• Record ID: K962963
• Device Name: CHECKMATE ANKLE RESTRAINT SYSTEM
• Applicant: Hollister, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Oct 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Indications for Use

The Checkmate Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a bed or gurney. The Checkmate Ankle Restraint System is intended to secure the patient’s ankles by keeping them in a fixed position.

Device Story

The Checkmate Ankle Restraint System is a physical restraint device used in clinical settings to secure a patient's ankles to a bed or gurney. It consists of two quilted ankle cuffs made of polyester and polyurethane foam laminate, connected by a 33-inch woven polypropylene security strap. The cuffs are secured around the patient's ankles using Velcro hook-and-loop fasteners and a Double D-Ring closure system. Webbed straps at the ends of the security strap anchor the system to the bed frame. The device is operated by healthcare staff to maintain patient positioning and control.

Clinical Evidence

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

Technological Characteristics

Materials: Woven polypropylene fabric (security strap), polyester and polyurethane foam laminate (cuffs). Closure: Velcro hook-and-loop and Double D-Ring. Dimensions: 4 inches wide, 33 inches long security strap. Mechanical restraint system; no energy source or software.

Indications for Use

Indicated for patients requiring physical restraint of the ankles while lying on a bed or gurney to maintain a fixed position for patient control.

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

• Checkmate Ankle Restraint System (K962963)

Submission Summary (Full Text)

{0}

K962963

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

OCT 24 1996

Heelbo, Inc.
Checkmate Ankle Restraint System

# Safety and Effectiveness Summary

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

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

Date Summary Prepared - July 25, 1996

## 2. Name of Device:

Checkmate Ankle Restraint System

## 3. Name of Predicate Device(s)

Checkmate Ankle Restraint System

## 4. Description of Device

The Checkmate Ankle Restraint System is designed for situations requiring patient control. The Checkmate System is a restraint system that secures the patient’s ankles in a fixed position. It consists of two individual quilted ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed from a woven polypropylene fabric that is 4 inches wide and 33 inches long. The webbed straps attached to both ends of the security strap secure the ankle restraint system to a bed or gurney. The individual ankle restraints are made of a soft polyester and polyurethane foam laminate that forms a cuff that closes around the patient’s ankle. The ankle restraint is held securely closed with Velcro® (hook and loop) and a Double D-Ring closure with strap.

## 5. Statement of Intended Use

The Checkmate Ankle Restraint System is intended to be used in situations requiring patient control while the patient is lying on a bed or gurney. The Checkmate Ankle Restraint System is intended to secure the patient’s ankles by keeping them in a fixed position.

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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.
Checkmate Ankle Restraint System

## 6. Statement of Technological Characteristics of the Device

The Checkmate Ankle Restraint System is designed for situations requiring patient control. The Checkmate System is a restraint system that secures the patient’s ankles in a fixed position. It consists of two individual quilted ankle restraints that are permanently attached at a specific distance apart from each other to a long security strap. The security strap is constructed from a woven polypropylene fabric that is 4 inches wide and 33 inches long. The webbed straps attached to both ends of the security strap secure the ankle restraint system to a bed or gurney. The individual ankle restraints are made of a soft polyester and polyurethane foam laminate that forms a cuff that closes around the patient’s ankle. The ankle restraint is held securely closed with Velcro® (hook and loop) and a Double D-Ring closure with strap.

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.

## 8. Conclusion

Based upon the information presented above it is concluded that the proposed Checkmate Ankle Restraint System is safe and effective for its intended use and is substantially equivalent to the predicate device.

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