(84 days)
The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails.
The Heelbo Pullover Poncho and Pullover Poncho with Pocket are poncho-style safety vests. The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails. The Heelbo Pullover Poncho has two straps that secure to the bed frame, wheelchair or geri-chair frame while the Pullover Poncho with Pocket has four straps that secure the bed frame, wheelchair or geri-chair frame. The Pullover Poncho with pocket provides the patient with a pocket to put personal items in. Both Heelbo Poncho restraints are available in a poly/cotton blend or a polyester mesh material and are available in five sizes to accommodate a wide range of patients. Both styles of pullover poncho are machine washable for continued use.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The text describes the device, its intended use, and states that it is substantially equivalent to predicate devices, but lacks the details requested in your prompt.
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Image /page/0/Picture/1 description: The image shows the number 0004. The first two zeros are followed by the number 4. To the left of the first zero is a small image of a square with a triangle in it.
Image /page/0/Picture/2 description: The image shows a handwritten number that appears to be "K963099". The number is written in a bold, black font, and the digits are clearly legible. The number is likely a serial number, product code, or other identifier.
Image /page/0/Picture/3 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black and appears to be the name of a company. The word "Heelbo" is followed by a comma and then "Inc."
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
NOV 1 1996
Heelbo, Inc. Pullover Poncho and Pullover Poncho with Pocket
510(k) Summary
1. 1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Chicago, IL 60651 Contact Person Joseph S. Tokarz, Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)680-2849, Fax (847)918-3860 Ph
Date Summary Prepared - October 30, 1996
2. Name of Device:
Heelbo Pullover Poncho and Pullover Poncho with Pocket
3. Name of Predicate Device(s)
Heelbo Pullover Poncho and Pullover Poncho with Pocket
4. Description of Device
The Heelbo Pullover Poncho and Pullover Poncho with Pocket are poncho-style safety vests. The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails. The Heelbo Pullover Poncho has two straps that secure to the bed frame, wheelchair or geri-chair frame while the Pullover Poncho with Pocket has four straps that secure the bed frame, wheelchair or geri-chair frame. The Pullover Poncho with pocket provides the patient with a pocket to put personal items in.
Both Heelbo Poncho restraints are available in a poly/cotton blend or a polyester mesh material and are available in five sizes to accommodate a wide range of patients. Both styles of pullover poncho are machine washable for continued use.
The following chart shows product availability:
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Image /page/1/Picture/1 description: The image shows a logo or symbol next to the number 0005. The logo appears to be a square with a checkmark inside. The number 0005 is written in a simple, sans-serif font and is likely a reference number or identifier.
Image /page/1/Picture/2 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black and appears to be the name of a company or organization. The comma after "Heelbo" is slightly raised, and the "Inc." is abbreviated with a period.
1134 N. Homan Ave Chicago, IL 60651 312/489-7711
Telex RCA 297-248
800/323-5444
Fax 312/489-7744
Heelbo, Inc. Pullover Poncho and Pullover Poncho with Pocket
| Size of Vest | Material | Color |
|---|---|---|
| x-small | Poly/Cotton blend | White |
| small | Poly/Cotton blend | Yellow |
| medium | Poly/Cotton blend | Blue |
| large | Poly/Cotton blend | Green |
| x-large | Poly/Cotton blend | Beige |
| x-small | Polyester Mesh | White bias on white breezewear |
| small | Polyester Mesh | Yellow bias on white breezewear |
| medium | Polyester Mesh | Blue bias on white breezewear |
| large | Polyester Mesh | Green bias on white breezewear |
| x-large | Polyester Mesh | Beige bias on white breezewear |
5. Statement of Intended Use
The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and 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 Pullover Poncho and Pullover Poncho with Pocket are poncho-style safety vests. The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails. The Heelbo Pullover Poncho has two straps that secure to the bed frame, wheelchair or geri-chair frame while the Pullover Poncho with Pocket has four straps that secure the bed frame, wheelchair or geri-chair frame. The Pullover Poncho with pocket provides the patient with a pocket to put personal items in.
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.
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Image /page/2/Picture/1 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is arranged on a single line, with "Heelbo" followed by a comma and then "Inc." The text is black against a white background.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Pullover Poncho and Pullover Poncho with Pocket
7. Biocompatibility Assessment
The subject devices are identical in components materials to the predicate devices. The suppliers of the materials used 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 Pullover Poncho and Pullover Poncho with Pocket are safe and effective for their intended use and are substantially equivalent to the predicate devices.
§ 880.6760 Protective restraint.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.