FNM · Class II · 21 CFR 880.5550

FDA Product Code FNM: Mattress, Air Flotation, Alternating Pressure

Leading manufacturers include Kinetic Concepts, Inc., Span-America Medical Systems, Inc. and Huntleigh Technology, Inc..

102
Total
102
Cleared
134d
Avg days
1976
Since
102 devices
25–48 of 102
Cleared Jul 18, 1996
AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
K962123
Lumex, Inc.
General Hospital · 48d
Cleared Jun 14, 1996
POWERED LOW AIR LOSS MATTRESS SYSTEM
K961159
Span-America Medical Systems, Inc.
General Hospital · 84d
Cleared Apr 25, 1996
PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
K960620
Span-America Medical Systems, Inc.
General Hospital · 72d
Cleared Apr 17, 1996
AREMA II
K961129
Mellen Air Mfg., Inc.
General Hospital · 27d
Cleared Mar 22, 1996
ALTACARE
K955874
Asf Industries, Inc.
General Hospital · 85d
Cleared Mar 18, 1996
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
K960411
Invacare Corp.
General Hospital · 49d
Cleared Feb 06, 1996
THE AIRCEL SYSTEM
K954593
Marcon Group, Inc.
General Hospital · 126d
Cleared Jan 11, 1996
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
K954766
Span-America Medical Systems, Inc.
General Hospital · 86d
Cleared Oct 24, 1995
PRESSUREGUARD IV
K953503
Span-America Medical Systems, Inc.
General Hospital · 90d
Cleared Jun 28, 1995
BAZOOKA SYSTEM
K951469
Innovative Medical Systems, Inc.
General Hospital · 90d
Cleared Jun 06, 1995
PRESSUREGUARD IV
K951112
Span-America Medical Systems, Inc.
General Hospital · 88d
Cleared May 23, 1995
TRIADYNE
K944094
Kinetic Concepts, Inc.
General Hospital · 274d
Cleared Mar 15, 1994
TURBO II
K933402
Kinetic Concepts, Inc.
General Hospital · 246d
Cleared Nov 12, 1993
PRESSUREGUARD IV
K932681
Span-America Medical Systems, Inc.
General Hospital · 162d
Cleared Aug 02, 1993
PREMIUM
K930673
Kinetic Concepts, Inc.
General Hospital · 174d
Cleared Jul 27, 1993
SKYTRON LIFE ISLAND 21
K926045
Skytron, Div. the Kmw Group, Inc.
General Hospital · 238d
Cleared Aug 11, 1992
BIO THERAPY PLUS
K922205
Sunrise Medical, Inc.
General Hospital · 91d
Cleared Oct 03, 1990
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
K901901
Kinetic Concepts, Inc.
General Hospital · 159d
Cleared Mar 29, 1989
HUNTLEIGH DYNAMIC FLOTATION SYSTEM
K890012
Huntleigh Technology, Inc.
General Hospital · 85d
Cleared Aug 10, 1988
HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
K882644
Huntleigh Technology, Inc.
General Hospital · 44d
Cleared Jul 13, 1988
CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM
K882092
Gaymar Industries, Inc.
General Hospital · 55d
Cleared Sep 04, 1987
PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
K872228
American Pharmaseal Div. Ahsc
General Hospital · 87d
Cleared Mar 04, 1987
HUNTLEIGH BETA II HM85
K870681
Huntleigh Technology, Inc.
General Hospital · 13d
Cleared Jan 25, 1985
HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP
K844879
Huntleigh Technology, Inc.
General Hospital · 39d