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510(k) Data Aggregation
K Number
K972486Device Name
PRESSUREGUARD IV
Manufacturer
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
1998-02-20
(233 days)
Product Code
IKZ
Regulation Number
890.5225Why did this record match?
Product Code :
IKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the prevention and treatment of pressure ulcers. Patient lateral rotation of up to 30 degrees may also be used as a preventive tool against further complications associated with critically ill patients or immobility.
Device Description
The PressureGuard Turn Select is an air flotation, alternating pressure support system. It consists of a foam shell manufactured with medical grade, polyurethane foam that meets the California Technical Bulletin 117. The perimeter bolsters are designed to safely prompt the patient toward the center of the surface, facilitating safe transfers and edge-of-bed sittings. The inflation system is cradled and securely positioned within the foam shell. Through computerized technology, the internal air pressures of the inflation system are controlled to achieve four operating modes. The CENTER Mode provides a level supine surface. The FIXED ROLL Mode provides automatic turning, turning the patient to the left followed by a 2 hour dwell time, then returning to center for a 2 hour dwell time, followed by a turn to the right followed by a 2 hour dwell time. The CUSTOM ROLL Mode provides for selection of roll patterns, roll angles and dwell times to meet individual patient needs. The CPR Mode provides a firm surface to aid in CPR Procedures (with a crash board). A Service Required Feature is provided to alert the health care provider in the event of system malfunction. CPR Alarm and Lock-Out features are also included.
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K Number
K972111Device Name
RUMORS DYNAMIC AIR THERAPY UNIT
Manufacturer
HILL-ROM, INC.
Date Cleared
1998-02-02
(242 days)
Product Code
IKZ
Regulation Number
890.5225Why did this record match?
Product Code :
IKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RUMORS Dynamic Air Therapy® Unit is intended to be used on existing bed frames in areas throughout the patient care environment to treat or prevent pulmonary complications and pressure ulcers.
The Unit can operate in rotation mode to reduce pressure shear, friction and maceration while gently rotating the patient from side to side; it can operate in percussion and vibration mode by delivering percussion and vibration to the patient's chest to loosen secretions from the lung wall; and it can also be programmed to operate in a sequential mode of percussion and vibration therapies with and without rotation with patients up to 400 lbs. in weight. The RUMORS Unit also provides low airloss therapy. Low airloss therapy has been demonstrated to reduce the risk of pressure ulcers caused by loss of capillary circulation as well as be a valuable aid in the treatment of bed sores.
The RUMORS Dynamic Air Therapy® Unit is intended to be used to treat or prevent pulmonary complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from Continuous Lateral Rotation Therapy.
Device Description
The RUMORS Dynamic Air Therapy® Unit consists of an Air Supply Unit, a Mattress, and Valves. The Air Supply Unit contains the blower and controller, which utilizes touchscreen technology and can be programmed for patients up to 84 inches tall and 400 lbs. The controller manages low airloss, rotation, percussion, vibration, and combinations of these therapies. The mattress is 8 inches high, 80 inches long, and has adjustable width (32 or 35 inches). It has two layers of cushions: a top sleep surface with five independently controlled cushions and a bottom working surface containing proportional and percussion/vibration valves. The Unit utilizes twelve proportional valves and one percussion/vibration valve capable of producing percussion from 1Hz to 5Hz and vibration from 6Hz to 25Hz.
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K Number
K962788Device Name
CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM
Manufacturer
GAYMAR INDUSTRIES, INC.
Date Cleared
1997-04-30
(287 days)
Product Code
IKZ, FNM, IOQ
Regulation Number
890.5225Why did this record match?
Product Code :
IKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CLINI-DYNE rotational/low air loss system is a patient rotation, pressure relieving support system used for the treatment and prevention of decubitus ulcers, urinary tract blockage, to aid circulation and for complications associated with immobility.
Device Description
The CLINI-DYNE Rotational Therapy System consists of an electromechanical inflation pump control unit which is connected to a mattress with cells (air filled bladders) through hose assemblies connected to the inflation pump. The system affords programmed patient position changes by gently turning the patient from supine to left side or right side and back to supine position when staff is unable to do so or needs assistance.
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K Number
K954671Device Name
THE FREEDOM BED
Manufacturer
PROBED MEDICAL TECHNOLOGIES, INC.
Date Cleared
1996-04-01
(174 days)
Product Code
IKZ
Regulation Number
890.5225Why did this record match?
Product Code :
IKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Freedom Bed PAR 3 is used to automatically reposition immobilized persons from side to side either manually or on a programmed schedule aide in the prevention of decubitus ulcers in bed ridden patients.
Device Description
The device is a programmable, automatically or manually operated repositioning bed designed for the prevention of decubitus ulcers. The device consists of 3 separate platen sections joined together with flexible hinges. The center section rotates left and right to a maximum of 30 degrees on each side, while the appropriate outer section rotates up to support and contain the sleeper. This provides a surface to transfer weight onto, as well as prevents the user from sliding or falling out of bed. The microprocessor based controller provides adjustment of time, angle and speed, as well as a choice of manual operation, automatic operation, or patient control. This allows most users to achieve independence from night time attendants and higher quality and duration of sleep. The bed has received UL 544, CSA, and FCC approvals.
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