(42 days)
Not Found
No
The device description focuses on mechanical components and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device's stated purpose is to provide restraint and upper body/posture support, not to treat or diagnose a medical condition.
No
The device description states its purpose is to provide "restraint and upper body support for patients in wheelchairs and restraint for patients in bed," and to provide "posture support," None of these functions involve diagnosing a condition or disease.
No
The device description clearly describes a physical garment (vest) made of fabric and webbing, which is a hardware component, not software.
No, 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.
- Support Vest function: The Support Vest is a physical restraint and support device applied externally to the patient's body. It does not involve testing any biological samples.
The provided information clearly describes a physical support and restraint device, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Support Vest is intended to provide restraint and upper body support for patients in wheelchairs and restraint for patients in bed.
Product codes
Not Found
Device Description
The Support Vest is a sleeveless, upper body device that has a poncho-style front bib and vest-style rear wings. These wings have 1 1/8-inch-wide polyester webbing sewn to them and brought around to the front of the device, and passed through two slots on the front bib. This closes the vest and causes the wings to criss-cross over the patient's middle chest thus providing posture support. The webbing secures to the wheelchair kickspurs or to the bed frame. The device is edged in bias cut binding in colors that correspond to a size chart included on the package insert. The device is intended for use in the bed or wheelchair.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients in wheelchairs and restraint for patients in bed / nursing homes, health care facilities
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Support Vest marketed by Skil-Care Corporation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3910 Wheelchair accessory.
(a)
Identification. A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.(b)
Classification. Class I (general controls). If the device is not intended for use as a protective restraint as defined in § 880.6760 of this chapter, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records, and § 820.198, regarding complaint files.
0
OCT 1 5 1006
Image /page/0/Picture/1 description: The image shows an address: 167 Saw Mill River Road, Yonkers, New York 10701. The address is written in a clear, sans-serif font. The text is horizontally aligned and takes up most of the image space.
Image /page/0/Picture/2 description: The image shows the logo for Skil-Care Corporation. The words "Skil-Care" are in a bold, sans-serif font, with a line underneath the word "Care". Below the logo is the word "CORPORATION" in a smaller, sans-serif font.
(914) 963-2040
(800) 431-2972
FAX (914) 963-2567
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 1-914-963-2567 Fax:
Contact person: Arnold Silverman
Date summary was prepared: August 27, 1996
Device name:
Trade name: Common name: Classification name: Support Vest Same Wheelchair accessory
Predicate device:
Support Vest marketed by Skil-Care Corporation
Device Description:
The Support Vest is a sleeveless, upper body device that has a poncho-style front bib and vest-style rear wings. These wings have 1 1/8-inch-wide polyester webbing sewn to them and brought around to the front of the device, and passed through two slots on the front bib. This closes the vest and causes the wings to criss-cross over the patient's middle chest thus providing posture support. The webbing secures to the wheelchair kickspurs or to the bed frame. The device is edged in bias cut binding in colors that correspond to a size chart included on the package insert. The device is intended for use in the bed or wheelchair.
式
1
Indications for use:
The Support Vest is intended to provide restraint and upper body support for patients in wheelchairs and restraint for patients in bed.
Comparative information:
The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): Support Vest.
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 five 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.
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.