IOQ · Class II · 21 CFR 890.5170

FDA Product Code IOQ: Bed, Flotation Therapy, Powered

Leading manufacturers include Hill-Rom, Inc., Kinetic Concepts, Inc. and Bio Clinic Co..

57
Total
57
Cleared
101d
Avg days
1977
Since
57 devices
25–48 of 57
Cleared Dec 20, 1991
TURBO
K912854
Kinetic Concepts, Inc.
Physical Medicine · 175d
Cleared Nov 22, 1991
MICROAIR 3500
K914674
Gsi Development Co.
Physical Medicine · 35d
Cleared Nov 13, 1991
CLA-1400 SYSTEM
K914851
Gaymar Industries, Inc.
Physical Medicine · 16d
Cleared Sep 06, 1991
HAZEL
K912855
Kinetic Concepts, Inc.
Physical Medicine · 70d
Cleared May 15, 1991
TASSI MK3 (TURNAIR)
K910851
Therapy Air Support Systems, Inc.
Physical Medicine · 76d
Cleared Dec 19, 1990
COMFORT-AIRE
K905126
Advanced Air Dynamics, Inc.
Physical Medicine · 35d
Cleared Nov 27, 1990
BIO MEDX AIR FLOTATION SYSTEM
K905156
Bio Clinic Co.
Physical Medicine · 12d
Cleared Nov 26, 1990
STAGE ZERO AIR FLOTATION BED
K905053
Lake Medical Products, Inc.
Physical Medicine · 18d
Cleared Sep 17, 1990
STAGE III
K903659
Unique Flotation Systems, Inc.
Physical Medicine · 39d
Cleared May 07, 1990
MARK IV FLOATATION THERAPY BED
K901890
Hydrothermic Floatation Systems, Inc.
Physical Medicine · 11d
Cleared Mar 30, 1990
PULMONAIR 40 PATIENT MANAGEMENT SYSTEM
K901295
The Medical Group, Inc.
Physical Medicine · 10d
Cleared Aug 17, 1989
SYSTEM 2500 MEDICAL WATERBED
K894723
Dermanetics Corp.
Physical Medicine · 23d
Cleared Aug 09, 1989
ORTHODERM CONVERTIBLE
K894353
Health Products, Inc.
Physical Medicine · 26d
Cleared Jul 25, 1989
M.F.S. LOW AIR LOSS PULSATING BED
K893801
Medical Flotation Systems, Inc.
Physical Medicine · 64d
Cleared Jun 22, 1989
AEROMAT MRS-1000
K893614
Integrated Therapy Products, Inc.
Physical Medicine · 43d
Cleared Jun 22, 1989
FLUIDIZED AIR BED
K893708
Gsi Development Co.
Physical Medicine · 35d
Cleared Mar 15, 1989
SYSTEM 3000 FLUIDIZED AIR BED
K890935
Dermanetics Corp.
Physical Medicine · 19d
Cleared Dec 01, 1988
ADD-ON TO CRITICAL PATIENT CARE BED
K882177
Cardio Systems, Inc.
Physical Medicine · 191d
Cleared Oct 26, 1988
PEDIATRIC HOSPITAL BED
K881843
The Medical Group, Inc.
Physical Medicine · 177d
Cleared Oct 26, 1988
SMI 3000 AIRBED
K883192
Smi Patientcare, Inc.
Physical Medicine · 90d
Cleared Oct 14, 1988
ULTRAFLOTATION BED
K882607
Medical Flotation Systems, Inc.
Physical Medicine · 112d
Cleared Aug 16, 1988
AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS
K882229
Biologics Intl., Inc.
Physical Medicine · 88d
Cleared Feb 22, 1988
DERMGARD SYSTEM 800 AND 900
K880486
Dermgard, Inc.
Physical Medicine · 18d
Cleared Jan 27, 1988
MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE
K875321
Kinetic Concepts, Inc.
Physical Medicine · 29d