FNM · Class II · 21 CFR 880.5550

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

Leading manufacturers include Kinetic Concepts, Inc., Gaymar Industries, Inc. and Medline Industries, Inc..

102
Total
102
Cleared
134d
Avg days
1976
Since

FDA 510(k) Cleared Mattress, Air Flotation, Alternating Pressure Devices (Product Code FNM)

102 devices
1–24 of 102
Cleared Nov 18, 1997
SIMPULSE
K972549
Kinetic Concepts, Inc.
General Hospital · 133d
Cleared Oct 23, 1997
BARIAIR
K955243
Kinetic Concepts, Inc.
General Hospital · 708d
Cleared Sep 05, 1997
KT AIR BED
K970468
Kinetic Concepts, Inc.
General Hospital · 210d
Cleared Jul 18, 1997
MODIFIED PEDIKAIR
K954320
Kinetic Concepts, Inc.
General Hospital · 680d
Cleared Aug 09, 1996
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854
Gaymar Industries, Inc.
General Hospital · 87d
Cleared Mar 18, 1996
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
K960411
Invacare Corp.
General Hospital · 49d
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 Aug 02, 1993
PREMIUM
K930673
Kinetic Concepts, Inc.
General Hospital · 174d
Cleared Oct 03, 1990
PROFILE, A CRITICAL CARE LOW AIR LOSS BED
K901901
Kinetic Concepts, Inc.
General Hospital · 159d
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 Feb 26, 1980
ABCO/GRANT ALTERNATING PRESSURE PAD & UT
K800231
Abco Dealers, Inc.
General Hospital · 21d
Cleared Aug 10, 1978
AIR-FLO ALTERNATING PRESSURE PAD SYSTEM
K780906
Gaymar Industries, Inc.
General Hospital · 69d
Cleared Aug 26, 1977
AERO PULSE ALTERNATING PRES. PUMP
K771463
Medline Industries, Inc.
General Hospital · 22d

About Product Code FNM - Regulatory Context