(87 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical restraint device with no mention of software, algorithms, or any technology that would incorporate AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is a safety vest designed to prevent a patient from slumping or sliding, which is a supportive function rather than a therapeutic treatment for a disease or condition.
No
The device description states its intended use is to prevent a patient from slumping or sliding forward while seated, which is a supportive function, not a diagnostic one that identifies or characterizes a medical condition.
No
The device description clearly states it is a physical vest with straps, made of fabric materials (polyester and cotton blend or polyester mesh), which are hardware components.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Heelbo Life Jacket with Crotch Support is a physical restraint/support device designed to prevent a patient from slumping or sliding in a chair. It does not involve testing any biological samples.
The description clearly indicates a physical support device for patient positioning, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
Product codes
Not Found
Device Description
The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
The Life Jacket with Crotch Support is available in a polyester and cotton blend (9400) or a polyester mesh material (9400B). The following chart shows product availability:
| Stock Number | Size of Vest | Color |
|---|---|---|
| 9400 | x-small | White |
| 9400 | small | Yellow |
| 9400 | medium | Blue |
| 9400 | large | Green |
| 9400 | x-large | Beige |
| 9400B | x-small | White bias on white breezewear |
| 9400B | small | Yellow bias on white breezewear |
| 9400B | medium | Blue bias on white breezewear |
| 9400B | large | Green bias on white breezewear |
| 9400B | x-large | Beige bias on white breezewear |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper torso
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Heelbo Life Jacket with Crotch Support
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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." in a bold, sans-serif font. The text is black and appears to be printed on a white background. A horizontal line is present underneath the text.
1134 N. Homan Ave. Chicago, IL 60651
Telex RCA 297-248 800/323-5444
16 31 130
312/489-7711
Fax 312/489-7744
Heelbo, Inc. Life Jacket with Crotch Support
510(k) Summary
1. 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 Ph (847)680-2849, Fax (847)918-3860
Date Summary Prepared - October 30, 1996
2. Name of Device:
Heelbo Life Jacket with Crotch Support
3. Name of Predicate Device(s)
Heelbo Life Jacket with Crotch Support
4. Description of Device
The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
The Life Jacket with Crotch Support is available in a polyester and cotton blend (9400) or a polyester mesh material (9400B). The following chart shows product availability:
| Stock Number | Size of Vest | Color |
|---|---|---|
| 9400 | x-small | White |
| 9400 | small | Yellow |
| 9400 | medium | Blue |
| 9400 | large | Green |
| 9400 | x-large | Beige |
| 9400B | x-small | White bias on white breezewear |
| 9400B | small | Yellow bias on white breezewear |
| 9400B | medium | Blue bias on white breezewear |
| 9400B | large | Green bias on white breezewear |
| 9400B | x-large | Beige bias on white breezewear |
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 appears to be the name of a company. There is a horizontal line underneath the text, which may be part of a logo or design element.
1134 N. Homan Ave. Telex RCA 297-248 Chicago, IL 60651 800/323-5444 312/489-7711 Fax 312/489-7744
Heelbo. Inc. Life Jacket with Crotch Support
5. Statement of Intended Use
The Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
6. Statement of Technological Characteristics of the Device
The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.
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 Life Jacket with Crotch Support is safe and effective for it's intended use and is substantially equivalent to the predicate device.