Panels › Physical Medicine › Product code IKZ · Class 2
Bed, Patient Rotation, Powered
Regulation 890.5225
0510(k)s in 12 months (17 all time)
0recalls in 12 months (12 all time)
0recalls that name a 510(k)
Top companies in IKZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Kinetic Concepts, Inc. | 3 | 2 |
| Arjo Hospital Equipment AB | 0 | 3 |
| Gaymar Industries, Inc. | 1 | 1 |
| Hill-Rom, Inc. | 2 | 0 |
| KCI USA, Inc. | 0 | 2 |
| ArjoHuntleigh Inc. | 0 | 1 |
| Arjohuntleigh Magog | 0 | 1 |
| Ethos Medical Products , Ltd. | 1 | 0 |
| Invacare Corp. | 1 | 0 |
| J. H. Emerson Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2021 | Kinsman Enterprises Inc Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths) Terminated |
IKZ | None listed |
| May 12, 2021 | Stryker Medical Division of Stryker Corporation Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Numb Open, Classified |
IKZ | None listed |
| Feb 5, 2019 | Arjohuntleigh Magog ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800 Terminated |
IKZ | None listed |
| Feb 27, 2015 | Arjo Hospital Equipment AB TriaDyne Proventa Critical Care Therapy System.
The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobil Terminated |
IKZ | None listed |
| Feb 27, 2015 | Arjo Hospital Equipment AB Rotoprone Therapy System.
The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. Terminated |
IKZ | None listed |
| Feb 27, 2015 | Arjo Hospital Equipment AB RotoRest Delta Advanced Therapy System.
The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications. Terminated |
IKZ | None listed |
| Feb 4, 2014 | ArjoHuntleigh Inc. The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and su Terminated |
IKZ | None listed |
| May 10, 2011 | KCI USA, Inc. KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500.
Indicated for treatment and prevention of pulmonary complications. Terminated |
IKZ | None listed |
| Dec 13, 2010 | KCI USA, Inc. RotoProne Therapy System, Model 209500, Device List Number E232632
Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It i Terminated |
IKZ | None listed |
| Feb 14, 2006 | Kinetic Concepts, Inc RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX. Terminated |
IKZ | None listed |
| Nov 30, 2004 | Gaymar Industries Inc XPRT Therapy Mattress Systems:
Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover).
Responsible fi Terminated |
IKZ | None listed |
| Jul 20, 2004 | Kinetic Concepts, Inc KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900 Terminated |
IKZ | None listed |
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