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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)
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Top companies in IKZ

DateFirm and productCodeLinked 510(k)
Sep 10, 2021Kinsman Enterprises Inc
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Terminated
IKZNone listed
May 12, 2021Stryker 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
IKZNone listed
Feb 5, 2019Arjohuntleigh Magog
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Terminated
IKZNone listed
Feb 27, 2015Arjo 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
IKZNone listed
Feb 27, 2015Arjo 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
IKZNone listed
Feb 27, 2015Arjo 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
IKZNone listed
Feb 4, 2014ArjoHuntleigh 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
IKZNone listed
May 10, 2011KCI 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
IKZNone listed
Dec 13, 2010KCI 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
IKZNone listed
Feb 14, 2006Kinetic Concepts, Inc
RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts, Inc., San Antonio, TX.
Terminated
IKZNone listed
Nov 30, 2004Gaymar 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
IKZNone listed
Jul 20, 2004Kinetic Concepts, Inc
KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900
Terminated
IKZNone listed

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