(51 days)
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No
The device description and intended use clearly describe a physical restraint vest with no mention of software, data processing, or any AI/ML related terms.
No
The device is a safety vest designed to provide support and limit patient movement, primarily to prevent falls. It does not treat or cure any medical condition.
No
This device is a safety vest designed to support patients and limit their movement, not to diagnose any medical conditions.
No
The device description clearly describes a physical garment (vest) made of fabric with straps and loops, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Heelbo Wrap Around Vest is a physical restraint device designed to support and limit patient movement. It does not involve testing any biological samples.
The description clearly indicates its purpose is to provide physical support and prevent falls or sliding, which are mechanical functions, not diagnostic ones.
N/A
Intended Use / Indications for Use
The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.
Product codes
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Device Description
The Heelbo Wrap Around Vest is a crisscross-style safety vest. The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying on a bed or gurney to prevent the patient from falling out of bed or climbing over the side rails.
The vest is secured to the bed or wheelchair frame with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed.
The Wrap Around Vest is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots (a picture of the loop accessory is attached to this section).
The Wrap Around Vest is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Wrap Around Vest is made of durable machine washable materials and is color coded for easy size identification.
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
Caregiver / wheelchair or geriatric chair, bed, gurney
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)
Heelbo Wrap Around Vest
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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/0 description: The image shows the text "Heelbo, Inc.". The text is in a bold, sans-serif font and is black. There is a line underneath the word "Heelbo".
1134 N. Homan Ave. Chicago, IL 60651
312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
OCT 11 1996
Heelbo, Inc. Wrap Around Vest
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:
ﭘﯿ
Date Summary Prepared - August 19, 1996
2. Name of Device:
Heelbo Wrap Around Vest
3. Name of Predicate Device(s)
Heelbo Wrap Around Vest
4. Description of Device
The Heelbo Wrap Around Vest is a crisscross-style safety vest. The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying on a bed or gurney to prevent the patient from falling out of bed or climbing over the side rails.
The vest is secured to the bed or wheelchair frame with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed.
The Wrap Around Vest is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots (a picture of the loop accessory is attached to this section).
The Wrap Around Vest is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Wrap Around Vest is made of durable machine washable materials and is color coded for easy size identification.
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. The words are arranged horizontally, with "Heelbo" on the first line and ", Inc." on the same line, slightly offset to the right.
1134 N. Homan Ave. Telex RCA 297-248 800/323-5444 Chicago, IL 60651 312/489-7711 - Fax 312/489-7744
Heelbo, Inc. Wrap Around Vest
ﭘﯿ
The following chart shows product availability:
The Wrap Around Vest Is Available in the following Sizes and Configurations
| Series | Material | Size of Vest | Color |
|---|---|---|---|
| 9420 | Poly/Cotton blend | x-small | White |
| 9420K* | small | Yellow | |
| medium | Blue | ||
| large | Green | ||
| x-large | Beige | ||
| 9420B* | Polyester Mesh material | x-small | White bias on white breezewear |
| small | Yellow bias on white breezewear | ||
| medium | Blue bias on white breezewear | ||
| large | Green bias on white breezewear | ||
| x-large | Beige bias on white breezewear |
* K=Knotless, B=Breezewear
)
5. Statement of Intended Use
The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying in bed or on a gurney 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 Wrap Around Vest is a crisscross-style safety vest. The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying on a bed or gurney to prevent the patient from falling out of bed or climbing over the side rails.
The vest is secured to the bed or wheelchair frame with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed.
2
Image /page/2/Picture/0 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
Heelbo, Inc. Wrap Around Vest
The Wrap Around Vest is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots
The Wrap Around Vest is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Wrap Around Vest is made of durable machine washable materials and is color coded for easy size identification.
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 Wrap Around Vest is safe and effective for its intended use and is substantially equivalent to the predicate device.