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510(k) Data Aggregation
K Number
K963091Device Name
VOLLMAN PRONE POSITIONER
Manufacturer
Date Cleared
1997-01-09
(154 days)
Product Code
Regulation Number
890.3490Why did this record match?
Product Code :
IPT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To assist caregivers in turning patients to or from the supine or prone position. Turning immobile patients can assist in treating pulmonary complications or disorders commonly associated with immobility.
Device Description
The Vollman Pronc Positioner Device is an independent, non-powered, portable accessory to any med-surg or critical care hospital bed with a flat surface that allows an immobile patient with respiratory complications, such as Acute Respiratory Distress Syndrome (ARDS) to be moved from a supine position to a prone position and held there. This position change occurs while the patient remains on either a regulation hospital frame (critical care or med-surg frame) or a therapeutic air support surface. This device allows this position change to be accomplished in most cases with only three caregivers. Currently, the most common method of proning a patient is manually lifting the patient and placing them prone. Other methods of proning a patient are the Stryker Wedge Turning Frame and the Stryker Circ-O-lectric Bed.
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