(34 days)
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No
The device descriptions and intended uses are purely mechanical and do not mention any computational or data-driven components.
No
The device is described as a safety belt and a reminder, not for treating a disease or condition.
No
The provided text describes devices (cushion belts) that serve as safety restraints and reminders to prevent patients from leaving a wheelchair or bed without assistance. There is no mention of these devices being used to diagnose any medical condition, disease, or provide information about the presence, absence, or severity of a disease or condition.
No
The device description clearly details physical components made of polyester, polyurethane foam, and webbing, indicating it is a physical medical device, not software-only.
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 Function: The described devices (Cushion Belts) are physical restraints or positioning aids used externally on patients in wheelchairs or beds. They do not involve testing biological samples.
- Intended Use: The intended use is for patient safety, preventing falls, and serving as a reminder not to leave a location without assistance. This is a mechanical or physical function, not a diagnostic one.
Therefore, these devices fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Cushion Belt is intended for patients who require a safety belt when in the wheelchair or bed. It is also used as a reminder not to leave the wheelchair or bed without assistance.
The Cushion Slider Belt is intended for patients who require a safety belt while in the wheelchair and who also need added control to prevent sliding down in the wheelchair.
The Adjusta-Loop Cushion Belt is intended for patients who require a safety belt while in the wheelchair and who require a reminder not to leave the wheelchair without assistance.
The Quick-Release Cushion Belt is intended for patients who require a safety belt while in the wheelchair and who require a reminder not to leave the wheelchair without assistance.
Product codes
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Device Description
Cushion Belt: A 26-inch-long, 6 1/2-inch wide cushion comprised of polyester on the outside and 3/4-inch-thick polyurethane foam inside. It has 1 1/2-inch-wide webbing and webbing loops sewn to each end. Webbing is polyester. Edges are finished with a bias cut binding. Webbing criss-crosses behind patient and secures to wheelchair or bed. Device is made in one size.
Cushion Slider Belt: Identical to above with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4-inch-thick polyurethane foam and has a 1 1/8-inch-wide strap sewn on that is either placed directly under the patient or under the wheelchair seat and secured to the cross brace under the wheelchair to prevent he patient from sliding down. This device is designed for wheelchair use only.
Adjusta-Loop Cushion Belt: Identical to the Cushion Belt except that the webbing is fitted with slider buckles that permit it to form adjustable loops that slip over the wheelchair kickspurs. The product is used by care givers who do not want to tie the webbing ends to the wheelchair. The device is intended for wheelchair use only.
Quick Release Cushion Belt: Identical to the Cushion belt except that one section of webbing is terminated with a "male" Delrin buckle component and the other end with a "female" Delrin buckle component. The buckle secures behind the wheelchair backrest.
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
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Indicated Patient Age Range
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Intended User / Care Setting
patients who require a safety belt, care givers, wheelchair or bed
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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 Skil-Care Corporation. The logo is in black and white, with the words "Skil-Care" in a bold, sans-serif font. The word "Corporation" is printed below in a smaller font. The logo is simple and professional.
167 Saw Mill River Road, Yonkers, New York 10701
TAB F: 510(k) Summary of Safety and Effectiveness
Name, address, phone and fax numbers for person submitting the 510(k) notification:
Arnold Silverman, President Skil-Care Corporation 167 Saw Mill River Road Yonkers, NY 10701 Phone: 1-914-963-2040 Fax: 1-914-963-2567
Contact person: Arnold Silverman
Date summary was prepared: August 27, 1996
Device name:
| Trade name: | Cushion Belt, Adjusta-Loop Cushion Belt
Quick-Release Cushion Belt, Cushion Slider Belt |
|----------------------|--------------------------------------------------------------------------------------------|
| Common name: | Same |
| Classification name: | Wheelchair Accessory |
Predicate device:
Cushion Belt, Adjusta-Loop Cushion Belt, Quick-Release Cushion Belt and Cushion Slider Belt marketed by Skil-Care Corporation.
Device Description:
Cushion Belt: A 26-inch-long, 6 1/2-inch wide cushion comprised of polyester on the outside and 3/4-inch-thick polyurethane foam inside. It has 1 1/2-inch-wide webbing and webbing loops sewn to each end. Webbing is polyester. Edges are finished with a bias cut binding. Webbing criss-crosses behind patient and secures to wheelchair or bed. Device is made in one size.
Cushion Slider Belt: Identical to above with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4-inch-thick polyurethane foam and has a 1 1/8-inch-wide strap sewn on that is either placed directly under the patient or under the wheelchair seat and secured to the cross brace under the wheelchair to prevent he patient from sliding down. This device is designed for wheelchair use only.
36
1
Adjusta-Loop Cushion Belt: Identical to the Cushion Belt except that the webbing is fitted with slider buckles that permit it to form adjustable loops that slip over the wheelchair kickspurs. The product is used by care givers who do not want to tie the webbing ends to the wheelchair. The device is intended for wheelchair use only.
Quick Release Cushion Belt: Identical to the Cushion belt except that one section of webbing is terminated with a "male" Delrin buckle component and the other end with a "female" Delrin buckle component. The buckle secures behind the wheelchair backrest.
Indications for use:
The Cushion Belt is intended for patients who require a safety belt when in the wheelchair or bed. It is also used as a reminder not to leave the wheelchair or bed without assistance.
The Cushion Slider Belt is intended for patients who require a safety belt while in the wheelchair and who also need added control to prevent sliding down in the wheelchair.
The Adjusta-Loop Cushion Belt is intended for patients who require a safety belt while in the wheelchair and who require a reminder not to leave the wheelchair without assistance.
The Quick-Release Cushion Belt is intended for patients who require a safety belt while in the wheelchair and who require a reminder not to leave the wheelchair without assistance.
Comparative information:
The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): Cushion Belt, Cushion Slider Belt, Adjusta-Loop Cushion Belt, Quick-Release Cushion Belt.
These devices are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by Skil-Care Corporation as of the date of this submission. Skil-Care Corporation has been marketing and commercially distributing these devices for approximately 18 years.
The difference from our currently marketed devices are that the labeling will be changed to incorporate many of the suggestions in FDA's draft document, "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints.
2
The use of all patient restraints in nursing homes are subject to Health Care Financing Administration's Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience. Further, most health care facilities are accredited. HCFA rules governing appropriate use and accreditation standards for device use and personnel training provide the control necessary to ensure that the devices are used correctly. The application of these standards along with public awareness and health care provider training have contributed significantly to ensuring that the least restrictive restraint is used, that restraints are used only when needed for proper medical treatment, and that their use is under appropriate supervision.
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