BEST STRAP RESTRAINT

K963371 · Morrison Medical Products · FMQ · Nov 7, 1996 · General Hospital

Device Facts

• Record ID: K963371
• Device Name: BEST STRAP RESTRAINT
• Applicant: Morrison Medical Products
• Product Code: FMQ · General Hospital
• Decision Date: Nov 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Indications for Use

The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient’s body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard.

Device Story

Restraint system consisting of five nylon straps with hook-and-loop fasteners; secures patient to backboard or stretcher frame at shoulder, chest, pelvis, thighs, and ankles. Straps are color-coded for application assistance; threaded around backboard/stretcher frame; secured via hook-and-loop for rapid application and release. Used in emergency medical services or clinical settings to stabilize patients during transport. Benefits include patient immobilization and safety during movement.

Clinical Evidence

No clinical data. Biocompatibility review of materials indicated low potential for adverse skin reaction; no reports of skin irritation noted.

Technological Characteristics

System comprised of five nylon straps with hook-and-loop fasteners. Color-coded for application. Mechanical restraint system; no energy source or software.

Indications for Use

Indicated for securing patients to backboards or stretcher frames at the shoulder, chest, pelvis, thighs, and ankles.

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

• Best Strap Restraint (k963371)

Submission Summary (Full Text)

{0}

MORRISON MEDICAL PRODUCTS
NOV - 7 1996
k963371

# Morrison Medical Products
## Best Strap Restraint

# Safety and Effectiveness Summary

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

| Submitter | Contact Person |
| --- | --- |
| Morrison Medical Products
610 W. Town Street
Columbus, OH 43215-4446 | Joseph S. Tokarz; Manager, Regulatory Affairs
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048
Ph: [phone], Fax: [phone] |

Date Summary Prepared - August 23, 1996

## 2. Name of Device:
Best Strap Restraint

## 3. Name of Predicate Device(s)
Best Strap Restraint

## 4. Description of Device
The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient’s body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher frame and secured with the Hook and Loop to allow for quick and easy application and release.

## 5. Statement of Intended Use
The Morrison Medical Best Strap Restraint is a restraint system intended to help to secure a patient’s body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard.

## 6. Statement of Technological Characteristics of the Device
The Morrison Medical Best Strap is a restraint system comprised of five nylon straps with Hook and Loop that helps to secure a patient’s body at the shoulder, chest, pelvis, thighs and ankles while lying on a backboard. The straps are color coded to assist in the application of the device. The straps are threaded around the backboard or stretcher

610 WEST TOWN STREET
COLUMBUS, OH 43215
FAX 614•469•96•96
614-461-4400

{1}

MORRISON MEDICAL PRODUCTS

# Morrison Medical Products
## Best Strap Restraint

frame and secured with the Hook and Loop to allow for quick and easy application and release.

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

The subject devices are identical in component materials to the predicate devices. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction.

## 8. Conclusion

Based upon the information presented above it is concluded that the proposed Morrison Medical Best Strap Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.

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610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400