(38 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven components. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as being used for "restraint" and "posture support," but not for treating or preventing a disease or condition. Therapeutic devices typically involve a medical claim.
No
Explanation: The device is described as a "restraint" and provides "posture support," with no mention of diagnosing any medical condition or processing any data for diagnostic purposes.
No
The device description clearly states it is a physical garment made of woven polyester or polyester mesh with straps and binding, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for restraint and posture support for the upper body in a wheelchair. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The device is a physical garment made of fabric and straps. It does not involve any reagents, instruments, or procedures for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
Therefore, the Safety Poncho and Shoulder Strap Poncho are considered medical devices used for physical support and restraint, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Safety Poncho is used for restraint. The Shoulder Strap Poncho provides restraint and posture support.
Product codes
Not Found
Device Description
Safety Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A waist strap secures the device to the wheelchair kickspurs. The strap is 1 1/8-inch-wide polyester webbing. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. The device is intended for wheelchair use only.
Shoulder Strap Poncho: The Shoulder Strap Poncho has the same configuration as the above with the addition of a strap sewn on the shoulder area. This strap ties to the wheelchair pushhandles to provide posture support. Strap is 1 1/8-inch-wide polyester webbing.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K96346
167 Saw Mi
liver Road, Yonkers, New York 10701
(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 Fax: 1-914-963-2567
Contact person: Arnold Silverman
Date summary was prepared: August 27, 1996
Device name:
Trade name: Common name: Classification name: Safety Poncho, Shoulder Strap Poncho Same Wheelchair Accessory
Predicate device:
Safety Poncho and Slider Poncho marketed by Skil-Care Corporation.
Device Description:
Safety Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A waist strap secures the device to the wheelchair kickspurs. The strap is 1 1/8-inch-wide polyester webbing. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. The device is intended for wheelchair use only.
Shoulder Strap Poncho: The Shoulder Strap Poncho has the same configuration as the above with the addition of a strap sewn on the shoulder area. This strap ties to the wheelchair pushhandles to provide posture support. Strap is 1 1/8-inch-wide polyester webbing.
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1
Indications for use:
The Safety Poncho is used for restraint.
The Shoulder Strap Poncho provides restraint and posture support.
Comparative information:
The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): The Safety Poncho and the Shoulder Strap Poncho.
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.
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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