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FNM — Mattress, Air Flotation, Alternating Pressure Class II

FDA Device Classification

FDA product code FNM covers "Mattress, Air Flotation, Alternating Pressure", a Class II medical device regulated under 21 CFR 880.5550. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FNM
Device Class
Class II
Regulation Number
880.5550
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K973169span-america medical systemsPRESSURE GUARD SITE SELECT (A)February 20, 1998
K974319wheelchairs of kansasMIGHTY AIRJanuary 22, 1998
K972022cardio systemsZAK-2000January 22, 1998
K974070physio designsPHYSIO/1000January 6, 1998
K972549kinetic conceptsSIMPULSENovember 18, 1997
K970081cathay consolidatedSUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMNovember 7, 1997
K955243kinetic conceptsBARIAIROctober 23, 1997
K970468kinetic conceptsKT AIR BEDSeptember 5, 1997
K965207skin care managementRID-DECUBE IIAugust 21, 1997
K972153decubiti conceptsALTERNATING PRESSURE AIR FLOTATION MATTRESSJuly 31, 1997
K954320kinetic conceptsMODIFIED PEDIKAIRJuly 18, 1997
K971568rest mattressREST MATTRESSJuly 18, 1997
K970362apex metalCARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEMMay 16, 1997
K970428restxsysREST X SYSTEMMay 14, 1997
K970350advanced air support consultancyEQUI-PISE 1000 MRSApril 22, 1997
K963674lumexLUMEX AIRJanuary 10, 1997
K962585united medical equipmentUNIT-MATT 5000 PRESSURE RELIEF SYSTEMJanuary 7, 1997
K9636209th wave9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMSJanuary 7, 1997
K9636269th wave9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESSNovember 26, 1996
K9636779th wave9TH WAVE MODEL 200 ALTERNATING PRESSURE PADNovember 26, 1996

FDA data resources