Bed, Air Fluidized
FDA product code INX · Class II (moderate risk) · 21 CFR 890.5160 · Physical Medicine
28510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Kinetic Concepts, Inc. 3
- Ssi Medical Services, Inc. 3
- Uhi Corp. 2
- Therapy Air Support Systems, Inc. 1
- Hill-Rom, Inc. 1
- Dynamedics, Inc. 1
- Ch Administration, Inc. 1
- Mellenair Ent., Inc. 1
- Support Systems Intl. 1
- Smith & Davis Mfg. Co. 1
- The Medical Group, Inc. 1
- Anacom General Corp. 1
- Unique Flotation Systems, Inc. 1
- Hsi Products, Inc. 1
- Gsi Development Co. 1
- Surgi-Med, Inc. 1
- Skytron, Div. The KMW Group, Inc 1
- Air Plus, Inc. 1
- Apollo Fluid Dynamics 1
- Bemco Mattress Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972176 | Home Care Bead BedINX · Traditional | Kinetic Concepts, Inc. | 01/16/1998SE |
| K964223 | Clinitron Rite-HiteINX · Traditional | Hill-Rom, Inc. | 05/28/1997SE |
| K943385 | Clinitron ElexisINX · Traditional | Ssi Medical Services, Inc. | 02/27/1995SE |
| K942184 | Clinitron at Home Air Fluided TherapyINX · Traditional | Ssi Medical Services, Inc. | 02/07/1995SE |
| K931168 | X-20 Air Support BedINX · Traditional | American Life Support Technology, Inc. | 02/17/1994SE |
| K934689 | Low Air Loss Mattress, ModificationINX · Traditional | Cardio Systems, Inc. | 02/02/1994SE |
| K924973 | Dylnamedics A.S.A.P.INX · Traditional | Dynamedics, Inc. | 10/15/1993SE |
| K926402 | Comfort Care Low Air Loss Therapy BedINX · Traditional | Ch Administration, Inc. | 03/24/1993SE |
| K924686 | Rem-AirINX · Traditional | Mellenair Ent., Inc. | 02/12/1993SE |
| K920112 | Clinitron C-IiINX · Traditional | Support Systems Intl. | 01/24/1992SE |
| K913654 | Smith and Davis Pressure Therapy SystemINX · Traditional | Smith & Davis Mfg. Co. | 11/22/1991SE |
| K911246 | The Mediscus Pedcare Management System-Model 2INX · Traditional | The Medical Group, Inc. | 06/06/1991SE |
| K911057 | Dermatek 4000INX · Traditional | Anacom General Corp. | 04/05/1991SE |
| K904008 | Stage IV, Air-Fluidize BedINX · Traditional | Unique Flotation Systems, Inc. | 10/10/1990SE |
| K890523 | SupercairINX · Traditional | Ssi Medical Services, Inc. | 02/10/1989SE |
| K884835 | Tassi MK2INX · Traditional | Therapy Air Support Systems, Inc. | 12/07/1988SE |
| K884529 | Microair Fluidized Air BedINX · Traditional | Gsi Development Co. | 11/18/1988SE |
| K881917 | FluidairINX · Traditional | Kinetic Concepts, Inc. | 11/14/1988SE |
| K881705 | Model 5000 Air-Fluidized Support SystemINX · Traditional | Surgi-Med, Inc. | 07/13/1988SE |
| K880340 | Modified Air Fluidized Bed, KinairINX · Traditional | Kinetic Concepts, Inc. | 02/16/1988SE |
| K870045 | Skytron Model 610-2INX · Traditional | Skytron, Div. the Kmw Group, Inc. | 02/04/1987SE |
| K852036 | Air Plus Air Fluidized Therapy SystemsINX · Traditional | Air Plus, Inc. | 09/05/1985SE |
| K843389 | Clinitron Air Fluidized Support J-101UDINX · Traditional | Uhi Corp. | 09/05/1984SE |
| K842987 | Apollo Air Fluidized BedINX · Traditional | Apollo Fluid Dynamics | 08/02/1984SE |
| K834344 | Med-Opedic Sleep SystemINX · Traditional | Bemco Mattress Co. | 01/17/1984SE |
| K813584 | Clinitron Air Fluidized Support SystemINX · Traditional | Uhi Corp. | 01/12/1982SE |
| K810543 | Neo-Wave SystemINX · Traditional | Gaymar Industries, Inc. | 03/06/1981SE |
| K760712 | Mediscus Air BedINX · Traditional | Hsi Products, Inc. | 11/24/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1132-2012 | Clinitron Rite Hite Bed headboard and foot side rails. The Clinitron Rite Hite Air…The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards… | Hill-Rom, Inc. | 02/03/2012Terminated |
| Z-1131-2012 | Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized…The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards… | Hill-Rom, Inc. | 02/03/2012Terminated |
| Z-1903-2009 | CLINITRON UP-LIFT" Air Fluidized Therapy Units. Intended to prevent and/or treat…Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the… | Hill-Rom Manufacturing, Inc. | 06/24/2009Terminated |
| Z-1902-2009 | CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure…Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the… | Hill-Rom Manufacturing, Inc. | 06/24/2009Terminated |