K963494 · Morrison Medical Products · FMQ · Nov 6, 1996 · General Hospital
Device Facts
Record ID
K963494
Device Name
MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP
Applicant
Morrison Medical Products
Product Code
FMQ · General Hospital
Decision Date
Nov 6, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.6760
Device Class
Class 1
Indications for Use
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient’s body while lying on a backboard.
Device Story
Disposable restraint strap; acrylic-coated polyester woven material; adhesive bands on ends. Operation: strap placed across patient body; woven through backboard hand holds; secured by adhering strap to itself. Removal: cut with scissors after use. Used in emergency medical services or clinical settings to secure patients to backboards. Benefit: prevents patient movement during transport.
Clinical Evidence
No clinical data. Biocompatibility based on history of use of identical materials in previously marketed devices with no reported skin irritation.
Indicated for patients requiring immobilization or securement to a backboard during transport or clinical care.
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
Morrison Medical Disposable Restraint Strap
Submission Summary (Full Text)
{0}
MORRISON MEDICAL PRODUCTS
NOV - 6 1996
X963494
# Morrison Medical Products
## Disposable Restraint Strap
# 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: (847)680-2849, Fax: (847)918-3860 |
Date Summary Prepared - August 29, 1996
## 2. Name of Device:
Morrison Medical Disposable Restraint Strap
## 3. Name of Predicate Device(s)
Morrison Medical Disposable Restraint Strap
## 4. Description of Device
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient’s body while lying on a backboard. The straps are constructed of an acrylic coated polyester woven material with an adhesive band on each end of the strap. The patient is secured to the backboard by lying the strap across the patient’s body and peeling the release paper from the strap. The strap is woven through the hand hold in the backboard and stuck back onto the polyester strap. After use the strap is cut off with scissors.
## 5. Statement of Intended Use
The Morrison Medical Disposable Restraint Strap is intended to help secure a patient’s body while lying on a backboard.
## 6. Statement of Technological Characteristics of the Device
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.
Page 18
610 WEST TOWN STREET
COLUMBUS, OH 43215
FAX 614•469•96•96
614-461-4400
{1}
MORRISON MEDICAL PRODUCTS
# Morrison Medical Products
## Disposable Restraint Strap
## 7. Biocompatibility
The materials used to manufacture this device are identical to a similar marketed device under comparable conditions of use. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in this device.
## 8. Conclusion
Based upon the information presented above it is concluded that the proposed Morrison Medical Disposable Restraint Strap is safe and effective for its intended use and is substantially equivalent to the predicate device.
610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400
