(72 days)
Not Found
Not Found
No
The device description details a physical limb restraint made of foam, fabric, and straps with mechanical closures. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
No.
The device's intended use is to limit patient movement for safety, examination, or protection, not to treat a medical condition.
No
The device is described as a protective limb restraint to limit movement and is not used for diagnosis.
No
The device description clearly details physical components made of foam, fabric, and polyester webbing, secured with D-rings or hook and loop closures, indicating it is a hardware device, not software.
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 description and intended use clearly state that the device is a protective limb restraint designed to limit patient movement. It is a physical device applied externally to the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect biomarkers, or provide any diagnostic information about a patient's health status.
Therefore, the Morrison Medical Products Limb Restraint with Double D-Ring and Strap is a physical medical device used for patient management and safety, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Morrison Medical Products Limb Restraint 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 position.
Product codes
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Device Description
Morrison Medical Products has developed two limb restraints that are intended to be a protective restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The following is a description of the two limb restraints.
Limb Restraint with Double D-Ring and Strap:
The Double D-Ring and Strap limb restraint uses it its construction a foam/fabric laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient's limb using a double D-ring closure mechanism.
The Limb Restraint with Double D-Ring and Strap is available in the following size:
Stock No. 1114 Adult Size:
Cuff size: 11½" long x 2½" wide Strap: 1" wide x 60" long
Limb Restraint with Strap:
The Limb Restraint with Strap is constructed of a foam laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient using a hook and loop closure.
The Limb Restraint with Strap is available in the following sizes:
Stock No. 1103 Adult size
Cuff size: 11½" long x 2½" wide Strap: 1" wide x 60" long
Stock No. 1124 Youth size
Cuff size: 9" long x 2" wide Strap: 1" wide x 36" long
Stock No. 1119 Infant size
Cuff size: 6" long x 1¼ wide Strap: 1" wide x 24" long
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb
Indicated Patient Age Range
Adult, Youth, Infant
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
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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.
Limb Restraint with Double D-Ring and Strap, Limb Restraint with Strap
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.
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 logo for Morrison Medical Products. The logo consists of a large, stylized letter "M" on the left, followed by the words "MORRISON", "MEDICAL", and "PRODUCTS" stacked vertically on the right. The text is in a bold, sans-serif font.
NOV - 8 1996
Morrison Medical Products Limb Restraint with Double D-Ring and Strap
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Contact Person Morrison Medical Products Joseph S. Tokarz: Manager, Regulatory Affairs Hollister Incorporated 610 W. Town Street 2000 Hollister Drive Columbus, OH 43215-4446 Libertyville, IL 60048 (847)680-2849, Fax: (847)918-3860 Ph:
Date Summary Prepared - August 26, 1996
2. Name of Device:
Limb Restraint with Double D-Ring and Strap Limb Restraint with Strap
3. Name of Predicate Device(s)
Limb Restraint with Double D-Ring and Strap Limb Restraint with Strap
4. Description of Device
Morrison Medical Products has developed two limb restraints that are intended to be a protective restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The following is a description of the two limb restraints.
Limb Restraint with Double D-Ring and Strap:
The Double D-Ring and Strap limb restraint uses it its construction a foam/fabric laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient's limb using a double D-ring closure mechanism.
The Limb Restraint with Double D-Ring and Strap is available in the following size:
Stock No. 1114 Adult Size:
Cuff size: 11½" long x 2½" wide Strap: 1" wide x 60" long
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Image /page/1/Picture/0 description: The image shows the logo for Morrison Medical Products. The logo consists of a large, bold letter "M" on the left side, followed by the words "MORRISON MEDICAL PRODUCTS" stacked on top of each other on the right side. The text is in a simple, sans-serif font and is all in black.
Morrison Medical Products Limb Restraint with Double D-Ring and Strap
Limb Restraint with Strap:
The Limb Restraint with Strap is constructed of a foam laminated material that is reinforced with a polyester webbing strap. The device is secured to the patient using a hook and loop closure.
The Limb Restraint with Strap is available in the following sizes:
| Stock No. 1103
Adult size | Cuff size: 11½" long x 2½" wide
Strap: 1" wide x 60" long |
|-------------------------------|--------------------------------------------------------------|
| Stock No. 1124
Youth size | Cuff size: 9" long x 2" wide
Strap: 1" wide x 36" long |
| Stock No. 1119
Infant size | Cuff size: 6" long x 1¼ wide
Strap: 1" wide x 24" long |
5. Statement of Intended Use
The Morrison Medical Products Limb Restraint 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 position.
6. Statement of Technological Characteristics of the Device
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
The subject devices are identical in component materials to the predicate devices. Morrison Medical Products is not aware of any reports or complaints of skin irritation associated with the materials used in these devices. A biocompatibility review of these materials indicated little potential to evoke an adverse reaction.
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Image /page/2/Picture/0 description: The image shows the logo for Morrison Medical Products. The logo consists of a large, stylized letter "M" on the left, followed by the words "MORRISON," "MEDICAL," and "PRODUCTS" stacked vertically on the right. The text is in a bold, sans-serif font, and the entire logo is in black and white.
Morrison Medical Products Limb Restraint with Double D-Ring and Strap
8. Conclusion
Based upon the information presented above it is concluded that the proposed Morrison Medical Products Limb Restraint with Double D-Ring and Strap is safe and effective for its intended use and is substantially equivalent to the predicate device.
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