Product code INX
- Device name
- Bed, Air Fluidized
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5160
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972176 | HOME CARE BEAD BED | Kinetic Concepts, Inc. | 1998-01-16 |
| K964223 | CLINITRON RITE-HITE | Hill-Rom, Inc. | 1997-05-28 |
| K943385 | CLINITRON ELEXIS | Ssi Medical Services, Inc. | 1995-02-27 |
| K942184 | CLINITRON AT HOME AIR FLUIDED THERAPY | Ssi Medical Services, Inc. | 1995-02-07 |
| K931168 | X-20 AIR SUPPORT BED | American Life Support Technology, Inc. | 1994-02-17 |
| K934689 | LOW AIR LOSS MATTRESS, MODIFICATION | Cardio Systems, Inc. | 1994-02-02 |
| K924973 | DYLNAMEDICS A.S.A.P. | Dynamedics, Inc. | 1993-10-15 |
| K926402 | COMFORT CARE LOW AIR LOSS THERAPY BED | Ch Administration, Inc. | 1993-03-24 |
| K924686 | REM-AIR | Mellenair Ent., Inc. | 1993-02-12 |
| K920112 | CLINITRON C-II | Support Systems Intl. | 1992-01-24 |
| K913654 | SMITH AND DAVIS PRESSURE THERAPY SYSTEM | Smith & Davis Mfg. Co. | 1991-11-22 |
| K911246 | THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 | The Medical Group, Inc. | 1991-06-06 |
| K911057 | DERMATEK 4000 | Anacom General Corp. | 1991-04-05 |
| K904008 | STAGE IV, AIR-FLUIDIZE BED | Unique Flotation Systems, Inc. | 1990-10-10 |
| K890523 | SUPERCAIR | Ssi Medical Services, Inc. | 1989-02-10 |
| K884835 | TASSI MK2 | Therapy Air Support Systems, Inc. | 1988-12-07 |
| K884529 | MICROAIR FLUIDIZED AIR BED | Gsi Development Co. | 1988-11-18 |
| K881917 | FLUIDAIR | Kinetic Concepts, Inc. | 1988-11-14 |
| K881705 | MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM | Surgi-Med, Inc. | 1988-07-13 |
| K880340 | MODIFIED AIR FLUIDIZED BED, KINAIR | Kinetic Concepts, Inc. | 1988-02-16 |
| K870045 | SKYTRON MODEL 610-2 | Skytron, Div. the Kmw Group, Inc. | 1987-02-04 |
| K852036 | AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS | Air Plus, Inc. | 1985-09-05 |
| K843389 | CLINITRON AIR FLUIDIZED SUPPORT J-101UD | Uhi Corp. | 1984-09-05 |
| K842987 | APOLLO AIR FLUIDIZED BED | Apollo Fluid Dynamics | 1984-08-02 |
| K834344 | MED-OPEDIC SLEEP SYSTEM | Bemco Mattress Co. | 1984-01-17 |
| K813584 | CLINITRON AIR FLUIDIZED SUPPORT SYSTEM | Uhi Corp. | 1982-01-12 |
| K810543 | NEO-WAVE SYSTEM | Gaymar Industries, Inc. | 1981-03-06 |
| K760712 | MEDISCUS AIR BED | Hsi Products, Inc. | 1976-11-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08720387388004 | AFCS PEARLS™ Control unit | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388011 | AFCS PEARLS™ Bed unit | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388028 | AFCS PEARLS™ Extension Hose | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388035 | AFCS PEARLS™ Air filter | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388042 | AFCS PEARLS™ Filter sheet large multifilament | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388059 | AFCS PEARLS™ Filter sheet small multifilament | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388066 | AFCS PEARLS™ Filter sheet large monofilament | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388073 | AFCS PEARLS™ Filter sheet small monofilament | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388110 | AFCS PEARLS™ & SANDS™ Corner clamps | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388127 | AFCS PEARLS™ Control unit | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388134 | AFCS PEARLS™ Traction support pole | Synergie Nederland B.V. | 2021-08-20 |
| 08720387388141 | AFCS PEARLS™ Backrest | Synergie Nederland B.V. | 2021-08-20 |
| B2844200002HU1 | HYDROAIRE | AURORA MANUFACTURING, LLC | 2017-02-17 |
| B2844200002INST1 | HYDROAIRE | AURORA MANUFACTURING, LLC | 2017-02-17 |
| 00887761013834 | Envella™ Bed | HILL-ROM, INC. | 2016-09-17 |
| 00887761996823 | Patient Helper | HILL-ROM, INC. | 2016-09-17 |