THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE
Device Facts
| Record ID | K962831 |
|---|---|
| Device Name | THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE |
| 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 |
Intended Use
The Inch Quilted Limb Holder with quick release closure 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
Quilted limb holder with Velcro fastener and quick-release snap closure; secures to beds, gurneys, chairs, or wheelchairs. Used by caregivers to limit patient movement for safety or treatment. Features wrist adjustment to prevent cinching; slide harness accommodates supine or sitting positions. Knotless snap closure allows rapid access to patient. Device is machine washable.
Clinical Evidence
No clinical data. Biocompatibility assessment based on history of safe use of materials in clothing/garment industry and lack of reported skin irritation.
Technological Characteristics
Quilted fabric limb holder; Velcro fastener; quick-release snap closure; straps for securement to furniture. Machine washable. No electronic or software components.
Indications for Use
Indicated for patients requiring limb restraint to limit movement for treatment, examination, or protection of the patient or others. Suitable 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
- The Inch Quilted Limb Holder with quick release snap closure
Related Devices
- K962832 — HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP · Heelbo, Inc. · Oct 18, 1996
- K962834 — HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP · Heelbo, Inc. · Oct 18, 1996
- K962839 — HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP · Heelbo, Inc. · Oct 18, 1996
- K963372 — HEELBO ER WRIST RESTRAINT · Heelbo, Inc. · Nov 7, 1996
- K963413 — MULTIPLE LIMB HOLDERS · J. T. Posey Co. · Nov 14, 1996
Submission Summary (Full Text)
{0}
Heelbo, Inc.
1134 N. Homan Ave.
Chicago, IL 60651
312/489-7711
Telex RCA 297-248
800/323-5444
Fax 312/489-7744
K 962831
Heelbo, Inc.
The Inch Quilted Limb Holder
OCT 18 1996
# 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: (847)680-2849, Fax: (847)918-3860 |
Date Summary Prepared - July 17, 1996
## 2. Name of Device:
The Inch Quilted Limb Holder with quick release snap closure
## 3. Name of Predicate Device(s)
The Inch Quilted Limb Holder with quick release snap closure
## 4. Description of Device
The Inch Quilted Limb Holder with quick release snap closure is a quilted limb holder with a Velcro® fastener, quick release snap closure and straps that secure to a bed, gurney, chair, geri-chair or wheelchair. The Inch Quilted Limb Holder with quick release closure 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 Inch allows for wrist adjustment to provide a secure fit without cinching. The knotless quick release snap closure is simple to use and allows the caregiver fast and easy access to the patient. A slide harness allows for supine or sitting positions. The Inch limb holders are machine washable.
The Inch Quilted Limb Holders are available in the following sizes, variations and types of assembly to accommodate the various needs of the user. (See chart on next page)
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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 312/489-7744
Heelbo, Inc.
The Inch Quilted Limb Holder
The Inch Quilted Limb Holder Availability
| Unit Pack | Series | Cuff Size(inches) | Description |
| --- | --- | --- | --- |
| 6 pr | 7700 | Small/Reg up to 11½" long | unassembled quick release snap closure
strap and one tie down strap |
| 6 pr | 7710 | Large/XL up to 12½" long | |
| 6 pr | 7715 | Small/Reg up to 11½" long | pre-threaded quick release snap closure
strap and one tie down strap |
| 6 pr | 7718 | Large/XL up to 12½" long | |
| 6 pr | 7700-DS | Small/Reg up to 11½" long | unassembled quick release snap closure
strap and two tie down straps |
| 6 pr | 7710-DS | Large/XL up to 12½" long | |
| 6 pr | 7720 | Small/Reg up to 11½" long | pre-threaded quick release snap closure
strap and one quick release loop accessory
(quick release loop accessory is replacement part*, series 7775) |
| 6 pr | 7725 | Large/XL up to 12½" long | |
| 6 pr | 7735 | Youth up to 9" long | |
| 6 pr | 7730 | toddler up to 9" long | toddler quilted limb holder with Velcro®
and two tie down straps |
| 10 ea | 7775 | replacement part | quick release loop accessory** |
* a quick release loop accessory that is secured to a chair/bed allows for fast release and eliminates the step of untying knots or cutting straps.
** Series 7775 is included with Series 7720, 7725 and 7735. It is also sold separately as a replacement part for Series 7720, 7725 and 7735.
5. Statement of Intended Use
The Inch Quilted Limb Holder with quick release closure 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
The Inch Quilted Limb Holder with quick release snap closure is a quilted limb holder with a Velcro® fastener, quick release snap closure and straps that secure to a bed, gurney, chair, geri-chair or wheelchair. The Inch Quilted Limb Holder with quick release closure 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 Inch allows for wrist adjustment to provide a secure fit without cinching. The knotless quick release snap closure is simple to use and allows the caregiver fast and easy access to the patient. A slide harness allows for supine or sitting positions.
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{2}
Heelbo, Inc.
1134 N. Homan Ave. Chicago, IL 60651
312/489-7711
Telex RCA 297-248
800/323-5444
Fax 312/489-7744
Heelbo, Inc.
The Inch Quilted Limb Holder
## 6. Statement of Technological Characteristics of the Device (con't)
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 Inch Quilted Limb Holders are safe and effective for their intended use and are substantially equivalent to the predicate device.
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