(34 days)
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No
The device description is purely mechanical and there is no mention of any computational or intelligent features.
No.
The device's intended use is for patient safety and as a reminder not to leave the wheelchair without assistance, which are supportive functions rather than direct treatment or prevention of a medical condition.
No
Explanation: The Econo Belt is described as a safety belt for a wheelchair, intended to keep a patient seated and remind them not to leave without assistance. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly states it is a physical belt made from nylon webbing with metal buckles, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Econo Belt Function: The Econo Belt is a physical restraint device used to secure a patient in a wheelchair. It does not interact with or analyze any biological specimens. Its function is purely mechanical and related to patient safety and positioning.
The description clearly indicates its purpose is to provide a safety belt and a reminder for a patient in a wheelchair, which falls under the category of a physical support or restraint device, not an IVD.
N/A
Intended Use / Indications for Use
The Econo Belt is intended for the patient who requires a safety belt while seated in the wheelchair and who requires a reminder not to leave the wheelchair without assistance.
Product codes
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Device Description
The Econo Belt is a two-inch-wide, six-foot-long wheelchair safety belt made from nylon webbing. Both ends have sewn loops which can be adjusted in size by means of metal slider buckles. The belt is positioned over the patient's waist, criss-crossed behind the wheelchair, and looped over the kickspurs. It is designed for wheelchair use only .
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
Not Found
Indicated Patient Age Range
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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
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)
Econo Belt
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
OCT - 7 1996
CORPORATI
167 Saw Mill River Road, Yonkers, New York 10701
FAX
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: Econo Belt Wheelchair Safety Belt Wheelchair Accessory
Predicate device:
Econo Belt marketed by Skil-Care Corporation.
Device Description:
The Econo Belt is a two-inch-wide, six-foot-long wheelchair safety belt made from nylon webbing. Both ends have sewn loops which can be adjusted in size by means of metal slider buckles. The belt is positioned over the patient's waist, criss-crossed behind the wheelchair, and looped over the kickspurs. It is designed for wheelchair use only .
Indications for use:
The Econo Belt is intended for the patient who requires a safety belt while seated in the wheelchair and who requires a reminder not to leave the wheelchair without assistance.
1
Comparative information:
The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): Econo 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.
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.