(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" field is also explicitly marked as "Not Found".
No.
The device is described as a protective limb restraint that limits movement for treatment, examination, or protection, rather than directly treating a medical condition or restoring function.
No
This device is described as a protective limb restraint that limits patient movement for treatment, examination, or protection, not to diagnose a condition.
No
The device description clearly outlines a physical product made of quilted material, Velcro, D-rings, and straps, which are all hardware components. There is no mention of any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "protective limb restraint that limits the patient's movement". This is a physical restraint used on a patient's body.
- Device Description: The description details a physical product (quilted limb holder with straps and rings) designed to be attached to a patient's limb and a support structure (bed, chair, etc.).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
This device falls under the category of a physical medical device used for patient management and safety, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Heelbo Quilted Limb Holder with Double D-Ring and Strap 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
Heelbo Quilted Limb Holder with Double D-Ring and Strap is a quilted limb holder with a Velcro® fastener, Double D-Ring and Straps that secure to a bed, gurney, chair, gerichair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring and Strap 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 adjustable Double D-Ring allows for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.
The Heelbo Quilted Limb Holder with Double D-Ring and Strap is available in the following sizes: Stock No. 9320 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long Stock No. 9330 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Heelbo Quilted Limb Holder with Double D-Ring and Strap
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/0 description: The image shows the text "Heelbo, Inc.". The text is in a bold, sans-serif font. The word "Heelbo" is followed by a comma, and then the word "Inc.".
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. Heelbo Quilted Limb Holder with Double D-Ring and Strap
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:
Date Summary Prepared - July 17, 1996
2. Name of Device:
Heelbo Quilted Limb Holder with Double D-Ring and Strap
3. Name of Predicate Device(s)
Heelbo Quilted Limb Holder with Double D-Ring and Strap
4. Description of Device
Heelbo Quilted Limb Holder with Double D-Ring and Strap is a quilted limb holder with a Velcro® fastener, Double D-Ring and Straps that secure to a bed, gurney, chair, gerichair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring and Strap 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 adjustable Double D-Ring allows for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.
The Heelbo Quilted Limb Holder with Double D-Ring and Strap is available in the following sizes: Stock No. 9320 Stock No. 9330
Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long
Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long
5. Statement of Intended Use
Heelbo Quilted Limb Holder with Double D-Ring and Strap 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.
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 word "Heelbo" is followed by a comma, and then "Inc." is written after the comma.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. Heelbo Quilted Limb Holder with Double D-Ring and Strap
6. Statement of Technological Characteristics of the Device
Heelbo Quilted Limb Holder with Double D-Ring and Strap is a quilted limb holder with a Velcro® fastener, Double D-Ring and Straps that secure to a bed, gurney, chair gerichair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring and Strap 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 adjustable Double D-Ring allows for supine and sitting positions.
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(kk)] 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.
Conclusion
Based upon the information presented above it is concluded that the Heelbo Quilted Limb Holder with Double D-Ring and Strap is safe and effective for its intended use and is substantially equivalent to the predicate device.