(88 days)
Not Found
Not Found
No
The device description and intended use describe a physical restraint device with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also explicitly marked as "Not Found".
No
The device is a limb restraint used to limit patient movement for safety and treatment purposes, not to provide therapy itself.
No
The provided text describes a limb holder, which is a protective restraint device. Its intended use is to limit patient movement for treatment, examination, or protection, not to diagnose a condition.
No
The device description clearly outlines a physical product (quilted limb holder with Velcro, snap closure, and straps) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be a protective limb restraint that limits patient movement. This is a physical restraint device used externally on the body.
- Device Description: The description details a physical product (quilted limb holder with fasteners and straps) used for physical restraint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing biological samples.
Therefore, this device falls under the category of a physical medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions
Product codes
Not Found
Device Description
The Inch Quilted Limb Holder with quick release snap closure is a quilted limb holder with a Velcro® fastener, quick release snap closure and straps that secure to a bed, gurney, chair, geri-chair or wheelchair. The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Inch allows for wrist adjustment to provide a secure fit without cinching. The knotless quick release snap closure is simple to use and allows the caregiver fast and easy access to the patient. A slide harness allows for supine or sitting positions. The Inch limb holders are machine washable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Key Metrics
Not Found
Predicate Device(s)
The Inch Quilted Limb Holder with quick release snap closure
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 is set against a white background. A thin black line underlines the text, adding a subtle visual element to the composition.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
OCT 18 1996
Heelbo, Inc. The Inch Quilted Limb Holder
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Heelbo, Inc. 1134 N. Homan Ave. 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 - July 17, 1996
2. Name of Device:
The Inch Quilted Limb Holder with quick release snap closure
3. Name of Predicate Device(s)
The Inch Quilted Limb Holder with quick release snap closure
4. Description of Device
The Inch Quilted Limb Holder with quick release snap closure is a quilted limb holder with a Velcro® fastener, quick release snap closure and straps that secure to a bed, gurney, chair, geri-chair or wheelchair. The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Inch allows for wrist adjustment to provide a secure fit without cinching. The knotless quick release snap closure is simple to use and allows the caregiver fast and easy access to the patient. A slide harness allows for supine or sitting positions. The Inch limb holders are machine washable.
The Inch Quilted Limb Holders are available in the following sizes, variations and types of assembly to accommodate the various needs of the user. (See chart on next page)
1
Heelbo. Inc
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. The Inch Quilted Limb Holder
| The Inch Quilted Limb Holder Availability | |||
|---|---|---|---|
| Unit | Series | Cuff Size(inches) | Description |
| Pack | |||
| 6 pr | 7700 | Small/Reg up to 11½" long | unassembled quick release snap closure |
| 6 pr | 7710 | Large/XL up to 12½" long | strap and one tie down strap |
| 6 pr | 7715 | Small/Reg up to 11½" long | pre-threaded quick release snap closure |
| 6 pr | 7718 | Large/XL up to 12½" long | strap and one tie down strap |
| 6 pr | 7700-DS | Small/Reg up to 11½" long | unassembled quick release snap closure |
| 6 pr | 7710-DS | Large/XL up to 12½" long | strap and two tie down straps |
| 6 pr | 7720 | Small/Reg up to 11½" long | pre-threaded quick release snap closure |
| 6 pr | 7725 | Large/XL up to 12½" long | strap and one quick release loop accessory |
| 6 pr | 7735 | Youth up to 9" long | (quick release loop accessory is |
| replacement part*, series 7775) | |||
| 6 pr | 7730 | toddler up to 9" long | toddler quilted limb holder with Velcro® |
| and two tie down straps | |||
| 10 ea | 7775 | replacement part | quick release loop accessory** |
・】 〇 ・ 1 ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
- a quick release loop accessory that is secured to a chair/bed allows for fast release and eliminates the step of untying knots or cutting straps.
- ** Series 7775 is included with Series 7720, 7725 and 7735. It is also sold separately as a replacement part for Series 7720, 7725 and 7735.
5. Statement of Intended Use
The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions
6. Statement of Technological Characteristics of the Device
The Inch Quilted Limb Holder with quick release snap closure is a quilted limb holder with a Velcro® fastener, quick release snap closure and straps that secure to a bed, gurney, chair, geri-chair or wheelchair. The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Inch allows for wrist adjustment to provide a secure fit without cinching. The knotless quick release snap closure is simple to use and allows the caregiver fast and easy access to the patient. A slide harness allows for supine or sitting positions.
2
Image /page/2/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.", which is likely an abbreviation for "Incorporated."
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. The Inch Ouilted Limb Holder
6. Statement of Technological Characteristics of the Device (con't)
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 Assessment
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 Inch Quilted Limb Holders are safe and effective for their intended use and are substantially equivalent to the predicate device.