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510(k) Data Aggregation
K Number
K963674Device Name
LUMEX AIR
Manufacturer
LUMEX, INC.
Date Cleared
1997-01-10
(119 days)
Product Code
FNM
Regulation Number
880.5550Why did this record match?
Applicant Name (Manufacturer) :
LUMEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Portable powered low air loss flotation therapy mattress.
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K Number
K962123Device Name
AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
Manufacturer
LUMEX, INC.
Date Cleared
1996-07-18
(48 days)
Product Code
FNM
Regulation Number
880.5550Why did this record match?
Applicant Name (Manufacturer) :
LUMEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss (LAL) (K923077) (K923977). Both Low Air Loss support systems consist of two operating components: 1. The electromechanical, computer controlled Air Control unit (ACU) 2. The Air Floatation Mattress. Both Systems promote pressure reduction by redistributing patient weight over a surface area / medium or by shifting patient we in a area / medium or by shifting patient weight of redistributing patient weight over a
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