Bed, Flotation Therapy, Powered

FDA product code IOQ · 56 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.5170
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-08-02 – 2013-06-03

IOQ 2013-06-03

TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2

Applicant Hill-Rom

K number K122473

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IOQ 1998-01-21

NURSE'S AID PATIENT ROTATION SYSTEM

Applicant Air Med Assist Products

K number K973624

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IOQ 1997-11-17

AIRTEC2 LOW AIR LOSS THERAPY BED

Applicant Apex Metal, Inc.

K number K970364

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IOQ 1997-11-17

HYDROTEC LOW AIR LOSS THERAPY BED

Applicant Apex Metal, Inc.

K number K970363

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IOQ 1997-08-26

TOTALCARE., MODULAR THERAPY SYSTEM (MTS)

Applicant Hill-Rom, Inc.

K number K970636

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IOQ 1997-07-03

SILKAIR LOW AIRLOSS THERAPY

Applicant Hill-Rom, Inc.

K number K964873

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IOQ 1997-05-16

FLEXICAIR EXLIPSE PLUS

Applicant Hill-Rom, Inc.

K number K970295

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IOQ 1995-07-31

TOTAL CONTACT SEAT RIPPLE SYSTEM

Applicant Numotech, Inc.

K number K943433

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IOQ 1995-06-27

FLEXICAIR EXLIPSE

Applicant Hill-Rom, Inc.

K number K951001

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IOQ 1995-02-27

DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE

Applicant Hill-Rom, Inc.

K number K945729

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IOQ 1995-02-10

CLENSICAIR LOW AIRLOSS HYDROTHERAPY

Applicant Support Systems Intl.

K number K941610

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IOQ 1994-06-15

I-5000

Applicant Support Systems Intl.

K number K940662

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IOQ 1993-12-21

THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM

Applicant Medical Device Inspection Co., Inc.

K number K931594

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IOQ 1993-07-21

PRISM

Applicant Bio Clinic Co.

K number K932480

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IOQ 1993-06-24

ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE

Applicant Bio Clinic Co.

K number K926189

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IOQ 1993-03-24

MICROAIR TURN-Q

Applicant Gsi Development Co.

K number K926456

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IOQ 1993-03-24

MICROAIR PUP

Applicant Gsi Medical Systems

K number K925694

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IOQ 1993-02-12

AKROTECH 4000

Applicant Lumex, Inc.

K number K923977

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IOQ 1992-07-30

RESTCUE CC

Applicant Support Systems Intl.

K number K922973

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IOQ 1992-05-27

ORTHODERM CONVERTIBLE II

Applicant Bio Clinic Co.

K number K922140

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IOQ 1992-04-29

HAZEL II

Applicant Kinetic Concepts, Inc.

K number K921768

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IOQ 1992-04-07

FLEXICAIR LOW AIRLOSS THERAPY UNIT

Applicant Support Systems Intl.

K number K920382

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IOQ 1992-01-13

B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT

Applicant Progressive Medical Technology, Inc.

K number K915671

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IOQ 1991-12-20

TURBO

Applicant Kinetic Concepts, Inc.

K number K912854

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IOQ 1991-11-22

MICROAIR 3500

Applicant Gsi Development Co.

K number K914674

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IOQ 1991-11-13

CLA-1400 SYSTEM

Applicant Gaymar Industries, Inc.

K number K914851

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IOQ 1991-09-06

HAZEL

Applicant Kinetic Concepts, Inc.

K number K912855

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IOQ 1991-05-15

TASSI MK3 (TURNAIR)

Applicant Therapy Air Support Systems, Inc.

K number K910851

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IOQ 1990-12-19

COMFORT-AIRE

Applicant Advanced Air Dynamics, Inc.

K number K905126

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IOQ 1990-11-27

BIO MEDX AIR FLOTATION SYSTEM

Applicant Bio Clinic Co.

K number K905156

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IOQ 1990-11-26

STAGE ZERO AIR FLOTATION BED

Applicant Lake Medical Products, Inc.

K number K905053

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IOQ 1990-09-17

STAGE III

Applicant Unique Flotation Systems, Inc.

K number K903659

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IOQ 1990-05-07

MARK IV FLOATATION THERAPY BED

Applicant Hydrothermic Floatation Systems, Inc.

K number K901890

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IOQ 1990-03-30

PULMONAIR 40 PATIENT MANAGEMENT SYSTEM

Applicant The Medical Group, Inc.

K number K901295

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IOQ 1989-08-17

SYSTEM 2500 MEDICAL WATERBED

Applicant Dermanetics Corp.

K number K894723

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IOQ 1989-08-09

ORTHODERM CONVERTIBLE

Applicant Health Products, Inc.

K number K894353

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IOQ 1989-07-25

M.F.S. LOW AIR LOSS PULSATING BED

Applicant Medical Flotation Systems, Inc.

K number K893801

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IOQ 1989-06-22

FLUIDIZED AIR BED

Applicant Gsi Development Co.

K number K893708

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IOQ 1989-06-22

AEROMAT MRS-1000

Applicant Integrated Therapy Products, Inc.

K number K893614

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IOQ 1989-03-15

SYSTEM 3000 FLUIDIZED AIR BED

Applicant Dermanetics Corp.

K number K890935

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IOQ 1988-12-01

ADD-ON TO CRITICAL PATIENT CARE BED

Applicant Cardio Systems, Inc.

K number K882177

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IOQ 1988-10-26

SMI 3000 AIRBED

Applicant Smi Patientcare, Inc.

K number K883192

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IOQ 1988-10-26

PEDIATRIC HOSPITAL BED

Applicant The Medical Group, Inc.

K number K881843

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IOQ 1988-10-14

ULTRAFLOTATION BED

Applicant Medical Flotation Systems, Inc.

K number K882607

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IOQ 1988-08-16

AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS

Applicant Biologics Intl., Inc.

K number K882229

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IOQ 1988-02-22

DERMGARD SYSTEM 800 AND 900

Applicant Dermgard, Inc.

K number K880486

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IOQ 1988-01-27

MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE

Applicant Kinetic Concepts, Inc.

K number K875321

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IOQ 1987-08-21

DECUB-I-CON 800 AND 900 SYSTEM

Applicant Wholesale Medical Supply, Inc.

K number K871614

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IOQ 1987-05-01

SCHELL C.A.P.P. BED MODEL NRS. 1268 + 1269

Applicant Schell B.V.

K number K871368

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IOQ 1986-12-16

ROTATION AIR FLUIDIZED BED/DELTA

Applicant Kinetic Concepts, Inc.

K number K864232

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IOQ 1986-09-05

FLEXICAIR

Applicant Ssi Medical Services, Inc.

K number K863047

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IOQ 1984-07-18

HOME CARE WATER FLOTATION BED HC4/TC/H

Applicant Western Medical, Ltd.

K number K840882

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IOQ 1984-07-18

WATER FLOATION BED 800/TC/H

Applicant Western Medical, Ltd.

K number K840881

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IOQ 1984-02-27

CALM WATER FLOTATION HOSPITAL BED

Applicant Calm Handicap Supplies, Inc.

K number K840697

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IOQ 1983-10-04

NEO-FLOAT NEONATAL FLOTATION SYS & RHYT

Applicant Clinical Data Instruments, Inc.

K number K832829

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IOQ 1977-08-02

FLOTATION THERAPY BED

Applicant Aquarius Medical Services

K number K771264

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