HEELBO BLAZER SLEEVED JACKET

{0} K 963243 Heelbo, Inc. 1134 N. Homan Ave. Telex RCA 297-248 Chicago, IL 60651 800/323-5444 312/489-7711 Fax 312/489-7744 OCT 1 1996 Heelbo, Inc. Blazer Sleeved Jacket # Safety and Effectiveness Summary ## 1. Submitter's name, Address and Contact Person | Submitter | Contact Person | | --- | --- | | Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651 | 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 14, 1996 ## 2. Name of Device: Heelbo Blazer Sleeved Jacket ## 3. Name of Predicate Device(s) Heelbo Blazer Sleeved Jacket ## 4. Description of Device The Heelbo Blazer Sleeved Jacket is a jacket-style safety vest. The Heelbo Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Blazer Sleeved Jacket is also intended to limit the patient’s movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails. The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is secured to a bed or wheelchair with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed. The jacket has Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release. The Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots. The Blazer Sleeved Jacket is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Blazer Sleeved Jacket is Page 22 {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. Blazer Sleeved Jacket The Blazer Sleeved Jacket is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Blazer Sleeved Jacket is made of durable machine washable materials and is color coded for easy size identification. The chart below shows product availability: The Blazer Sleeved Jacket Is Available in the Following Sizes and Configurations | Series | Material | Size of Vest | Color | | --- | --- | --- | --- | | 9415 9415K | Poly/Cotton blend | x-small | White | | | | small | Yellow | | | | medium | Blue | | | | large | Green | | | | x-large | Beige | | 9415B 9415BK | Polyester Mesh material | x-small | White bias on white breezewear | | | | small | Yellow bias on white breezewear | | | | medium | Blue bias on white breezewear | | | | large | Green bias on white breezewear | | | | x-large | Beige bias on white breezewear | 5. Statement of Intended Use The Heelbo Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Blazer Sleeved Jacket is also intended to limit the patient’s movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails. 6. Statement of Technological Characteristics of the Device The Heelbo Blazer Sleeved Jacket is a jacket-style safety vest. The Heelbo Blazer Sleeved Jacket is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Blazer Sleeved Jacket is also intended to limit the patient’s movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails. Page 23 {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. Blazer Sleeved Jacket The jacket has short sleeves and straps on each side of the vest that can be tied together to ensure a comfortable fit. The jacket is secured to a bed or wheelchair with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed. The jacket has Velcro® fasteners and a zipper in the back to ensure a secure fit as well as allowing for quick and easy release. The Blazer Sleeved Jacket is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots. 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 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 Heelbo Blazer Sleeved Jacket is safe and effective for its intended use and is substantially equivalent to the predicate device. Page 24