(86 days)
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No
The description details a simple mechanical belt with fasteners and a buckle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a "security belt" intended to "secure a patient," which suggests a restraint or safety device, not one that treats or diagnoses a medical condition.
No
This device is a safety belt used to secure patients, not to diagnose a medical condition.
No
The device description clearly states it is a physical belt made of cotton with a buckle and fasteners, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Johnny Grait Belt Function: The Johnny Grait Belt Security Belt is a physical restraint device used to secure a patient. It does not perform any tests on bodily samples.
The provided information clearly describes a physical security belt, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney.
Product codes
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Device Description
The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chair commodes, wheelchairs, beds and gurneys.
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
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Key Metrics
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Predicate Device(s)
Heelbo Johnny Grait Belt 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.
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Image /page/0/Picture/1 description: The image shows the text "Heelbo, Inc.". The text is in a bold, sans-serif font. The text is black and the background is white.
1134 N. Homan Ave. Chicago. IL 60651
Telex RCA 297-248 800/323-5444
312/489-7711
Fax 312/489-7744
OCT 2 4 1996
Heelbo, Inc. Johnny Grait Belt Security Belt
510(k) Summary
1. 1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Chicago, IL
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 22, 1996
2. Name of Device:
Heelbo Johnny Grait Belt Security Belt
3. Name of Predicate Device(s)
Heelbo Johnny Grait Belt Security Belt
4. Description of Device
The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chair commodes, wheelchairs, beds and gurneys.
The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney.
5. Statement of Intended Use
The Johnny Grait Belt Security Belt is intended to be used as a safety belt to secure a patient who is seated in a wheelchair or geri-chair. It is also used to secure a patient sitting on a chair commode or lying on a bed or gurney.
1
Image /page/1/Picture/0 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 word "Heelbo" is followed by a comma, and then "Inc." is written after the comma.
1134 N. Homan Ave. Chicago, IL 60651
Telex RCA 297-248 800/323-5444
312/489-7711
Fax 312/489-7744
Heelbo, Inc. Johnny Grait Belt Security Belt
6. Statement of Technological Characteristics of the Device
The Heelbo Johnny Grait Belt Security Belt is a security belt made of cotton with a polypropylene, quick release snap buckle closure and two D-Ring Velcro loop fasteners. The belt is 2 inches wide and 60 inches long to accommodate a wide range of patients. The Velcro fasteners quickly attach and detach to chair commodes, wheelchairs, beds and gurneys.
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.
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 Johnny Grait Belt Security Belt is safe and effective for it's intended use and is substantially equivalent to the predicate device.