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510(k) Data Aggregation
K Number
K973624Device Name
NURSE'S AID PATIENT ROTATION SYSTEM
Manufacturer
AIR MED ASSIST PRODUCTS
Date Cleared
1998-01-21
(120 days)
Product Code
IOQ
Regulation Number
890.5170Why did this record match?
Applicant Name (Manufacturer) :
AIR MED ASSIST PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used to provide cushioning, torso support and totation (by manually-controlled alternating pressure) with pressure-relieving capabilities, as well as provide an aid to a nurse or other care-giver, in the home, we read foinical setting, to assist a patient in shifting their body position, to minimize possibility of bed sores, or other problems that can result from lying or sitting in one position for excessive periods of time.
Device Description
An air-flotation, alternating pressure mattress, with detachable electric pump/compressor, reuseable, with available washable/disposable mattress cover.
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