INX · Class II · 21 CFR 890.5160

FDA Product Code INX: Bed, Air Fluidized

Leading manufacturers include Kinetic Concepts, Inc., Ssi Medical Services, Inc. and Uhi Corp..

28
Total
28
Cleared
106d
Avg days
1976
Since

FDA 510(k) Cleared Bed, Air Fluidized Devices (Product Code INX)

28 devices
1–24 of 28
Cleared Jan 16, 1998
HOME CARE BEAD BED
K972176
Kinetic Concepts, Inc.
Physical Medicine · 221d
Cleared May 28, 1997
CLINITRON RITE-HITE
K964223
Hill-Rom, Inc.
Physical Medicine · 217d
Cleared Feb 27, 1995
CLINITRON ELEXIS
K943385
Ssi Medical Services, Inc.
Physical Medicine · 229d
Cleared Feb 07, 1995
CLINITRON AT HOME AIR FLUIDED THERAPY
K942184
Ssi Medical Services, Inc.
Physical Medicine · 279d
Cleared Feb 17, 1994
X-20 AIR SUPPORT BED
K931168
American Life Support Technology, Inc.
Physical Medicine · 346d
Cleared Feb 02, 1994
LOW AIR LOSS MATTRESS, MODIFICATION
K934689
Cardio Systems, Inc.
Physical Medicine · 163d
Cleared Oct 15, 1993
DYLNAMEDICS A.S.A.P.
K924973
Dynamedics, Inc.
Physical Medicine · 380d
Cleared Mar 24, 1993
COMFORT CARE LOW AIR LOSS THERAPY BED
K926402
Ch Administration, Inc.
Physical Medicine · 93d
Cleared Feb 12, 1993
REM-AIR
K924686
Mellenair Ent., Inc.
Physical Medicine · 149d
Cleared Jan 24, 1992
CLINITRON C-II
K920112
Support Systems Intl.
Physical Medicine · 14d
Cleared Nov 22, 1991
SMITH AND DAVIS PRESSURE THERAPY SYSTEM
K913654
Smith & Davis Mfg. Co.
Physical Medicine · 98d
Cleared Jun 06, 1991
THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2
K911246
The Medical Group, Inc.
Physical Medicine · 77d
Cleared Apr 05, 1991
DERMATEK 4000
K911057
Anacom General Corp.
Physical Medicine · 28d
Cleared Oct 10, 1990
STAGE IV, AIR-FLUIDIZE BED
K904008
Unique Flotation Systems, Inc.
Physical Medicine · 42d
Cleared Feb 10, 1989
SUPERCAIR
K890523
Ssi Medical Services, Inc.
Physical Medicine · 8d
Cleared Dec 07, 1988
TASSI MK2
K884835
Therapy Air Support Systems, Inc.
Physical Medicine · 19d
Cleared Nov 18, 1988
MICROAIR FLUIDIZED AIR BED
K884529
Gsi Development Co.
Physical Medicine · 21d
Cleared Nov 14, 1988
FLUIDAIR
K881917
Kinetic Concepts, Inc.
Physical Medicine · 189d
Cleared Jul 13, 1988
MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM
K881705
Surgi-Med, Inc.
Physical Medicine · 85d
Cleared Feb 16, 1988
MODIFIED AIR FLUIDIZED BED, KINAIR
K880340
Kinetic Concepts, Inc.
Physical Medicine · 21d
Cleared Feb 04, 1987
SKYTRON MODEL 610-2
K870045
Skytron, Div. the Kmw Group, Inc.
Physical Medicine · 30d
Cleared Sep 05, 1985
AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS
K852036
Air Plus, Inc.
Physical Medicine · 119d
Cleared Sep 05, 1984
CLINITRON AIR FLUIDIZED SUPPORT J-101UD
K843389
Uhi Corp.
Physical Medicine · 7d
Cleared Aug 02, 1984
APOLLO AIR FLUIDIZED BED
K842987
Apollo Fluid Dynamics
Physical Medicine · 3d

About Product Code INX - Regulatory Context