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510(k) Data Aggregation
K Number
K152056Device Name
Winco Model S550 Stretchair
Manufacturer
WINCO MANUFACTURING LLC
Date Cleared
2016-04-11
(262 days)
Product Code
INK
Regulation Number
890.3690Why did this record match?
Applicant Name (Manufacturer) :
WINCO MANUFACTURING LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Winco Model S550 Stretchair is to provide a method of transporting patients within healthcare facilities.
Device Description
The Winco Model S550 Stretchair is a battery powered device designed for use in healthcare facilities. Its' intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.
The Winco Model S550 Stretchair has a powered height adjustment feature which allows patient surface to be raised and lowered for patient mounting and patient access. It also has a powered linear actuator which changes the patient surface from a sitting position to a laying (supine) position.
The patient can be transported only when in the seated position. When in the supine position, it can be used to transfer a patient to/from a bed, gurney or other patient support surface. The Winco Model S550 Stretchair is for patients weighing up to 550 Ibs. It is intended for indoor use only, by trained medical staff and health care personnel. There is no drive mechanism or power assist for moving the product from one physical location to another. This is performed manually by the medical staff. The device cannot be self-propelled by the patient.
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