(58 days)
Heelbo Quilted Torso Restraint
Not Found
No
The device description and intended use clearly describe a physical restraint device with no mention of software, data processing, or AI/ML terms.
No
The device is described as a restraint to secure a patient, not to treat a medical condition or ailment.
No
The device is described as a restraint used to secure a patient, not to diagnose a condition or disease.
No
The device description clearly states it is a physical belt made of reinforced, padded material with polyester webbed strapping and a buckle, indicating it is a hardware device.
Based on the provided information, 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 Description and Intended Use: The Heelbo Quilted Torso Restraint is a physical restraint device used to secure a patient's torso or legs. It does not involve testing samples from the body.
Therefore, it falls outside the scope of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Heelbo Quilted Torso Restraint is intended to help secure a patient at the torso or legs while lying on a bed or gurney.
Product codes
Not Found
Device Description
The Heelbo Quilted Torso Restraint is a reinforced, padded belt 4½ inches wide by 33½ inches long. The Quilted Torso Restraint is designed with polyester webbed strapping that is wrapped around the frame of a bed or gurney and threaded through a drop-jaw buckle to secure the patient at the torso or legs.
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
torso or legs
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Heelbo Quilted Torso Restraint
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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." 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
OCT - 9 1996
Heelbo, Inc. Quilted Torso Restraint
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
| Submitter | Contact Person |
|---|---|
| Heelbo, Inc. | |
| 1134 N. Homan Ave. | |
| Chicago, IL 60651 | 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 - August 8, 1996 |
- Name of Device:
Heelbo Quilted Torso Restraint
3. Name of Predicate Device(s)
Heelbo Quilted Torso Restraint
4. Description of Device
The Heelbo Quilted Torso Restraint is a reinforced, padded belt 4½ inches wide by 33½ inches long. The Quilted Torso Restraint is designed with polyester webbed strapping that is wrapped around the frame of a bed or gurney and threaded through a drop-jaw buckle to secure the patient at the torso or legs.
5. Statement of Intended Use
The Heelbo Quilted Torso Restraint is intended to help secure a patient at the torso or legs while lying on a bed or gurney.
6. Statement of Technological Characteristics of the Device
The Heelbo Quilted Torso Restraint is a reinforced, padded belt 4½ inches wide by 33½ inches long. The Quilted Torso Restraint is designed with polyester webbed strapping that is wrapped around the frame of a bed or gurney and threaded through a drop-iaw buckle to secure the patient at the torso or legs.
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
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 comma after "Heelbo" and the period after "Inc." are clearly visible.
1134 N. Homan Ave. Chicago, IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
and the country of the submit and the subsequence a
Heelbo, Inc. Quilted Torso Restraint
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 Quilted Torso Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.