(89 days)
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No
The device description is purely mechanical and there is no mention of AI, ML, or any computational processing.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is described as a security belt to help secure a patient and does not treat or prevent any medical condition.
No
The device description clearly states its purpose is to secure a patient in a wheelchair or geriatric chair, which is a physical restraint function, not a diagnostic one.
No
The device description clearly describes a physical belt with straps, indicating it is a hardware device, not software.
Based on the provided information, the Heelbo Security Belt is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "help secure the patient while seated in a wheelchair or geriatric chair." This is a physical restraint or positioning device used on the patient's body.
- Device Description: The description details a padded belt with straps for physical attachment to a chair.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or condition based on in vitro analysis.
- Any laboratory or analytical procedures.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. The Heelbo Security Belt is a physical support/restraint device used on the body.
N/A
Intended Use / Indications for Use
The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair.
Product codes
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Device Description
The Heelbo Security Belt is a padded belt 4% inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.
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
Not Found
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
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Key Metrics
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Predicate Device(s)
Heelbo Security Belt
Reference Device(s)
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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
63060
Image /page/0/Picture/2 description: The image shows the word "Heelbo, Inc." in bold black font. The words are on a white background. There is a thin black line underneath the words.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444
Fax 312/489-7744
NOW 4 1888
Heelbo. Inc. Security Belt
510(k) Summary
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 - November 1, 1996
2. Name of Device:
Heelbo Security Belt
3. Name of Predicate Device(s)
Heelbo Security Belt
4. Description of Device
The Heelbo Security Belt is a padded belt 4% inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.
5. Statement of Intended Use
The Heelbo Security Belt is intended to help secure the patient while seated in a wheelchair or geriatric chair.
6. Statement of Technological Characteristics of the Device
The Heelbo Security Belt is a padded belt 4% inches wide by 22 inches long with cotton webbed straps sewn onto both ends. The webbed straps tie to the frame of the wheelchair or geriatric chair to help secure the patient while seated.
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.
1
Image /page/1/Picture/2 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 present under the text, emphasizing the name.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Security Belt
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 Security Belt is safe and effective for its intended use and is substantially equivalent to the predicate device.