TORSO/WAIST RESTRAINT
K963374 · Morrison Medical Products · FMQ · Nov 8, 1996 · General Hospital
Device Facts
| Record ID | K963374 |
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| Device Name | TORSO/WAIST RESTRAINT |
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| Applicant | Morrison Medical Products |
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| Product Code | FMQ · General Hospital |
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| Decision Date | Nov 8, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 880.6760 |
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| Device Class | Class 1 |
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Intended Use
The Morrison Medical Torso/Waist Restraint is intended to help secure a patient at the torso and waist in an ambulance or other emergency vehicle while in transport to a hospital or other critical care facility.
Device Story
Device consists of two adjustable nylon over-the-shoulder straps and two adjustable nylon waist straps; all straps joined at waist and secured via metal push-button buckle and metal connectors. Used by emergency personnel to secure patients in supine or elevated positions on cots/stretchers during ambulance transport. Provides physical restraint to prevent patient movement during transit. Benefit includes patient stabilization and safety during emergency transport.
Clinical Evidence
No clinical data. Biocompatibility assessment based on material history and lack of reported skin irritation.
Technological Characteristics
Adjustable nylon webbing straps; metal push-button buckle and metal connectors. Manual operation. No electronic components or software.
Indications for Use
Indicated for patients requiring securement at the torso and waist while lying on a cot or stretcher in an ambulance or emergency vehicle during transport to a hospital or critical care facility.
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 Torso/Waist Restraint (K963374)
Related Devices
- K963906 — PATIENT RESTRAINTS · Safety Intl., Inc. · Dec 2, 1996
- K963371 — BEST STRAP RESTRAINT · Morrison Medical Products · Nov 7, 1996
- K963399 — MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS · Morrison Medical Products · Nov 6, 1996
- K963421 — PROTECTIVE RESTRAINT (WAIST HOLDER) · Kenad SG Medical, Inc. · Nov 22, 1996
- K963414 — MULTIPLE BELTS · J. T. Posey Co. · Nov 22, 1996
Submission Summary (Full Text)
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11/07/96 10:59 847 918 3860 004
MORRISON MEDICAL PRODUCTS NOV - 8 1996 K96 3374
# Morrison Medical Products
## Torso/Waist Restraint
### 510(k) Summary
1. 1. Submitter's name, Address and Contact Person
| Submitter | Contact Person |
| --- | --- |
| Morrison Medical Products Inc.
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 - November 7, 1996
2. Name of Device:
Morrison Medical Torso/Waist Restraint
3. Name of Predicate Device(s)
Morrison Medical Torso/Waist Restraint
4. Description of Device
The Morrison Medical Torso/Waist Restraint is intended to be used by emergency personnel to help secure a patient at the torso and waist, while lying on a cot or stretcher, in an ambulance or other emergency vehicle while in transport to a hospital or other critical care facility. The restraint can be used in the supine or elevated positions.
The Morrison Medical Torso/Waist Restraint is constructed by combining two adjustable, nylon, “over-the-shoulder” straps that secure the upper torso and two adjustable nylon straps that secure the waist. All four straps are joined at the waist and are secured with a metal push button buckle and metal connectors.
The nylon webbing is available in multiple colors.
5. Statement of Intended Use
The Morrison Medical Torso/Waist Restraint is intended to help secure a patient at the torso and waist in an ambulance or other emergency vehicle while in transport to a hospital or other critical care facility.
610 WEST TOWN STREET COLUMBUS, OH 43215 FAX 614•469•96•96 614-461-4400
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11/07/96 11:00 847 918 3860
005
M
MORRISON MEDICAL PRODUCTS
# Morrison Medical Products
## Torso/Waist Restraint
### 6. Statement of Technological Characteristics of the Device
The Morrison Medical Torso/Waist Restraint is constructed by combining two adjustable, nylon, “over-the-shoulder” straps that secure the upper torso and two adjustable nylon straps that secure the waist. All four straps are joined at the waist and are secured with a metal push button buckle and metal connectors. The Nylon webbing is available in multiple colors.
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 Assessment
The subject devices are identical in components 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 Torso/Waist Restraint 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
