(84 days)
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No
The device description and intended use focus on a physical restraint device with no mention of software, algorithms, or data processing.
No
The device is described as a restraint to limit movement, not to treat a medical condition or disease.
No
Explanation: The device is an arm restraint designed to limit movement, not to diagnose any condition.
No
The device description clearly states it is a physical product made of flexible plastic, foam fabric, and Velcro fasteners, which are hardware 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 physically restrain a patient's arm to limit movement. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical restraint made of plastic and fabric. It does not involve any reagents, instruments, or procedures for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring any substance or characteristic within the body for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The L-Bow Arm Restraint fits over the patient's elbow and is intended to limit the patient's movement, particularly away from their face and IV tubing, by keeping their arm in an extended position.
Product codes
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Device Description
The L-Bow Arm Restraint is constructed of a flexible plastic insert that is covered with soft polyester foam fabric held securely closed with Velcro® fasteners. The L-bow Arm Restraint is wrapped around the patient's elbow and is intended to limit the patient's movement, particularly away from their face and IV tubing, by keeping their arm in an extended position. The Velcro® fasteners are easy to use and offer a secure firm hold. The L-Bow may be machine washed.
The L-Bow is available in three sizes to accommodate various infant, toddler and youth sizes and two sizes to accommodate adults. The following are the sizes available:
Pediatric:
Infant (7" x 5", Stock No. 9380)
Toddler (8" x 6", Stock No. 9385)
Youth (10" x 8.5", Stock No. 9390)
Adult:
Medium (10" x 11", Stock No. 9395)
Large (12" x 13", Stock No. 9398)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
elbow
Indicated Patient Age Range
infant, toddler, youth, adult
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
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Key Metrics
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Predicate Device(s)
L-Bow Arm Restraint
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 abbreviation "Inc."
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. The L-Bow Arm Restraint
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 15, 1996
2. Name of Device:
L-Bow Arm Restraint
3. Name of Predicate Device(s)
· L-Bow Arm Restraint
4. Description of Device
The L-Bow Arm Restraint is constructed of a flexible plastic insert that is covered with soft polyester foam fabric held securely closed with Velcro® fasteners. The L-bow Arm Restraint is wrapped around the patient's elbow and is intended to limit the patient's movement, particularly away from their face and IV tubing, by keeping their arm in an extended position. The Velcro® fasteners are easy to use and offer a secure firm hold. The L-Bow may be machine washed.
The L-Bow is available in three sizes to accommodate various infant, toddler and youth sizes and two sizes to accommodate adults. The following are the sizes available:
| Pediatric | Adult | ||||
|---|---|---|---|---|---|
| Size | Dimensions | ||||
| (inches) | Stock No. | Size | Dimensions | ||
| (inches) | Stock No. | ||||
| Infant | 7" x 5" | 9380 | Medium | 10" x 11" | 9395 |
| Toddler | 8" x 6" | 9385 | Large | 12" x 13" | 9398 |
| Youth | 10" x 8.5" | 9390 |
1
Image /page/1/Picture/0 description: The image shows the text "Heelbo, Inc." in a bold, sans-serif font. The text is arranged horizontally, with "Heelbo" appearing first, followed by a comma, and then "Inc." The text is black against a white background, and there is a horizontal line below the text.
1134 N. Homan Ave. Chicago. IL 60651 312/489-7711
Telex RCA 297-248 800/323-5444 Fax 312/489-7744
Heelbo, Inc. The L-Bow Arm Restraint
5. Statement of Intended Use
The L-Bow Arm Restraint fits over the patient's elbow and is intended to limit the patient's movement, particularly away from their face and IV tubing, by keeping their arm in an extended position.
6. Statement of Technological Characteristics of the Device
The L-Bow Arm Restraint is constructed of a flexible plastic insert that is covered with soft polyester foam fabric held securely closed with Velcro® fasteners. The L-bow Arm Restraint is wrapped around the patient's elbow and is intended to limit the patient's movement, particularly away from their face and IV tubing, by keeping their arm in an extended position. The Velcro® fasteners are easy to use and offer a secure firm hold.
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 uselin 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 L-Bow Arm Restraint is safe and effective for its intended use and is substantially equivalent to the predicate device.