(88 days)
Heelbo Ouilted Limb Holder with Double D-Ring. Ouick-Release Snap, and Strap 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.
Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is a disposable quilted limb holder with a Velcro® fastener, Double D-Ring, Quick-Release Snap and Straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap 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 Heelbo Quilted Limb Holder allows for wrist adjustment to provide a secure fit without cinching. The Double D-Ring is simple to use and allows the caregiver easy access to the patient. Also, the adjustable Double D-Ring and Quick-Release Snap allow for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.
The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is available in the following sizes:
Stock No. 9350 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long
Stock No. 9360 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification summary for a medical device (Heelbo Quilted Limb Holder), focusing on its intended use, description, and substantial equivalence to a predicate device. It addresses aspects like technological characteristics and biocompatibility based on material history of safe use, but it does not detail specific performance metrics, clinical studies, or expert evaluations as requested in the prompt.
Therefore, I cannot extract the information needed to fill out the table and answer the questions about acceptance criteria and a detailed study.
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K96 2834
Image /page/0/Picture/1 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black and is set against a white background. A horizontal line is placed under the text.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
OCT 1 8 1996
Heelbo, Inc. Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Ave. Chicago, IL 60651
Contact Person 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 - July 17, 1996
2. Name of Device:
Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap
3. Name of Predicate Device
Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap
4. Description of Device
Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is a disposable quilted limb holder with a Velcro® fastener, Double D-Ring, Quick-Release Snap and Straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap 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 Heelbo Quilted Limb Holder allows for wrist adjustment to provide a secure fit without cinching. The Double D-Ring is simple to use and allows the caregiver easy access to the patient. Also, the adjustable Double D-Ring and Quick-Release Snap allow for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.
The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is available in the following sizes:
Stock No. 9350 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long
Stock No. 9360 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long
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Image /page/1/Picture/0 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is black against a white background. 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
Heelbo, Inc.
Heelbo Quilted Limb Holder with Double D-Ring, Ouick-Release Snap and Strap
5. Statement of Intended Use
Heelbo Ouilted Limb Holder with Double D-Ring. Ouick-Release Snap, and Strap 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
Heelbo Quilted Limb Holder with Double D-Ring, Ouick-Release Snap and Strap is a disposable quilted limb holder with a Velcro® fastener, Double D-Ring, Quick-Release Snap and Straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap 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 Heelbo Quilted Limb Holder allows for wrist adjustment to provide a secure fit without cinching. The Double D-Ring is simple to use and allows the caregiver easy access to the patient. Also, the adjustable Double D-Ring and Quick-Release Snap allow for supine and sitting positions.
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.
Conclusion
Based upon the information presented above it is concluded that the proposed Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap, and Strap is safe and effective for its intended use and is substantially equivalent to the predicate device.
§ 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.