Panels › Physical Medicine › Product code INX · Class 2
Bed, Air Fluidized
Regulation 890.5160
0510(k)s in 12 months (28 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in INX
| Company | 510(k)s | Recalls |
|---|---|---|
| Hill-Rom Manufacturing, Inc. | 0 | 5 |
| Kinetic Concepts, Inc. | 3 | 2 |
| Hill-Rom, Inc. | 1 | 2 |
| Ssi Medical Services, Inc. | 3 | 0 |
| Uhi Corp. | 2 | 0 |
| Air Plus, Inc. | 1 | 0 |
| American Life Support Technology, Inc. | 1 | 0 |
| Anacom General Corp. | 1 | 0 |
| Apollo Fluid Dynamics | 1 | 0 |
| Bemco Mattress Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2012 | Hill-Rom, Inc. Clinitron Rite Hite Bed headboard and foot side rails.
The Clinitron Rite Hite Air Fluidized Therapy Unit is a patient management system that combines air fluidized therapy and low airloss therapy te Terminated |
INX | K964223 |
| Mar 1, 2012 | Hill-Rom, Inc. Clinitron At Home Bed headboard and foot side rails.
The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable Terminated |
INX | K964223 |
| Aug 25, 2009 | Hill-Rom Manufacturing, Inc. CLINITRON UP-LIFT" Air Fluidized Therapy Units.
Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problem Terminated |
INX | K920112 |
| Aug 25, 2009 | Hill-Rom Manufacturing, Inc. CLINITRON CII Air Fluidized Therapy Units.
Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and Terminated |
INX | K813584 |
| Jul 20, 2004 | Kinetic Concepts, Inc KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080 Terminated |
INX | None listed |
| Oct 24, 2003 | Hill-Rom Manufacturing, Inc. Clinitron At Home Air Fluidized Therapy Unit Terminated |
INX | K942184 |
| Jul 10, 2003 | Hill-Rom Manufacturing, Inc. CLINITRON UP-LIFT Air Fluidized Therapy unit. Terminated |
INX | K920112 |
| Jul 10, 2003 | Hill-Rom Manufacturing, Inc. CLINITRON CII Air Fluidized Therapy unit. Terminated |
INX | K813584 |
| Apr 10, 2003 | Kinetic Concepts, Inc TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic Concepts, Inc. Terminated |
INX | None listed |
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