(78 days)
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No
The device description and intended use are purely mechanical and do not mention any computational or data-driven features.
No
The device is described as a restraint to secure a patient in a chair, which indicates a supportive/safety function rather than a therapeutic one aimed at treating a disease or condition. The inclusion of a catheter access slot is a design feature for patient convenience, not a therapeutic mechanism.
No
Explanation: The device description clearly states its purpose is to "help secure a patient while seated" and it has features like straps and a catheter access slot. It does not mention anything related to detecting, monitoring, or diagnosing a medical condition.
No
The device description clearly states it is constructed of polyester mesh and straps, indicating it is a physical, hardware-based medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Heelbo Pelvic Restraint Function: The Heelbo Pelvic Restraint is a physical restraint designed to secure a patient in a chair. It does not interact with or analyze any biological specimens from the patient. Its function is purely mechanical and related to patient positioning and safety.
The provided information clearly describes a physical restraint device, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Heelbo Pelvic Restraint is intended to help secure a patient while seated in a wheelchair or geriatric chair.
Product codes
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Device Description
The Heelbo Pelvic Restraint is constructed of polyester mesh. Straps sewn onto both sides of the front panel and back panel are used to secure the patient to the wheelchair or geriatric chair. A catheter access slot has been incorporated into the restraint design for those patients that utilize an indwelling catheter.
The Pelvic Restraints are available in three sizes, small, medium and large to accommodate a wide range of patients. The Pelvic Restraints are machine washable for continued use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Heelbo Pelvic Restraint
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the text "Heelbo, Inc.". The text is in a bold, sans-serif font and is black. The background is white. The text is likely the name of a company.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
1 1996
Heelbo, Inc. Pelvic Restraint
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 (847)680-2849, Fax: (847)918-3860 Ph:
Date Summary Prepared - August 13, 1996
2. Name of Device:
Heelbo Pelvic Restraint
3. Name of Predicate Device(s)
Heelbo Pelvic Restraint
4. Description of Device
The Heelbo Pelvic Restraint is constructed of polyester mesh. Straps sewn onto both sides of the front panel and back panel are used to secure the patient to the wheelchair or geriatric chair. A catheter access slot has been incorporated into the restraint design for those patients that utilize an indwelling catheter.
The Pelvic Restraints are available in three sizes, small, medium and large to accommodate a wide range of patients. The Pelvic Restraints are machine washable for continued use.
5. Statement of Intended Use
The Heelbo Pelvic Restraint is intended to help secure a patient while seated in a wheelchair or geriatric chair.
6. Statement of Technological Characteristics of the Device
The Heelbo Pelvic Restraint is constructed of polyester mesh. Straps sewn onto both sides of the front panel and back panel are used to secure the patient to the wheelchair or geriatric chair. A catheter access slot has been incorporated into the restraint design for those patients that utilize an indwelling catheter.
1
Image /page/1/Picture/0 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is arranged horizontally, with "Heelbo" appearing first, followed by a comma, and then "Inc." with a period at the end. A horizontal line is placed underneath the text.
1134 N. Homan Ave. Chicago. IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Pelvic Restraint
The Pelvic Restraints are available in three sizes, small, medium and large to accommodate a wide range of patients. The Pelvic Restraints are machine washable for continued use.
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 Pelvic Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.