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

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

102 devices
1–24 of 102
Cleared Feb 20, 1998
PRESSURE GUARD SITE SELECT (A)
K973169
Span-America Medical Systems, Inc.
General Hospital · 179d
Cleared Jan 22, 1998
ZAK-2000
K972022
Cardio Systems, Inc.
General Hospital · 234d
Cleared Jan 22, 1998
MIGHTY AIR
K974319
Wheelchairs of Kansas
General Hospital · 66d
Cleared Jan 06, 1998
PHYSIO/1000
K974070
Physio Designs, Inc.
General Hospital · 70d
Cleared Nov 18, 1997
SIMPULSE
K972549
Kinetic Concepts, Inc.
General Hospital · 133d
Cleared Nov 07, 1997
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
K970081
Cathay Consolidated, Inc.
General Hospital · 302d
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 Aug 21, 1997
RID-DECUBE II
K965207
Skin Care Management, Inc.
General Hospital · 237d
Cleared Jul 31, 1997
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
K972153
Decubiti Concepts, Inc.
General Hospital · 52d
Cleared Jul 18, 1997
MODIFIED PEDIKAIR
K954320
Kinetic Concepts, Inc.
General Hospital · 680d
Cleared Jul 18, 1997
REST MATTRESS
K971568
Rest Mattress
General Hospital · 80d
Cleared May 16, 1997
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
K970362
Apex Metal, Inc.
General Hospital · 105d
Cleared May 14, 1997
REST X SYSTEM
K970428
Restxsys
General Hospital · 99d
Cleared Apr 22, 1997
EQUI-PISE 1000 MRS
K970350
Advanced Air Support Consultancy, Inc.
General Hospital · 82d
Cleared Jan 10, 1997
LUMEX AIR
K963674
Lumex, Inc.
General Hospital · 119d
Cleared Jan 07, 1997
UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
K962585
United Medical Equipment, Inc.
General Hospital · 190d
Cleared Jan 07, 1997
9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
K963620
9th Wave, Inc.
General Hospital · 119d
Cleared Nov 26, 1996
APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM
K963510
Mellen Air Mfg., Inc.
General Hospital · 84d
Cleared Nov 26, 1996
9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS
K963626
9th Wave, Inc.
General Hospital · 76d
Cleared Nov 26, 1996
9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
K963677
9th Wave, Inc.
General Hospital · 74d
Cleared Oct 08, 1996
AIR-MEDEX I
K961769
Robert Gold Assoc.
General Hospital · 153d
Cleared Oct 02, 1996
PRESSUREGUARD: SELECTCARE
K960188
Span-America Medical Systems, Inc.
General Hospital · 260d
Cleared Aug 09, 1996
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854
Gaymar Industries, Inc.
General Hospital · 87d

About Product Code FNM - Regulatory Context