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Found 8 results
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?
Applicant Name (Manufacturer) :
SPAN-AMERICA MEDICAL SYSTEMS, INC.
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
K973169Device Name
PRESSURE GUARD SITE SELECT (A)
Manufacturer
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
1998-02-20
(179 days)
Product Code
FNM
Regulation Number
880.5550Why did this record match?
Applicant Name (Manufacturer) :
SPAN-AMERICA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the prevention and treatment of pressure ulcers.
Device Description
The PressureGuard Site Select is an air flotation, alternating pressure support system which provides for customized selection of surface firmness for a head, upper torso, lower torso, and heel zones.
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K Number
K960188Device Name
PRESSUREGUARD: SELECTCARE
Manufacturer
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
1996-10-02
(260 days)
Product Code
FNM
Regulation Number
880.5550Why did this record match?
Applicant Name (Manufacturer) :
SPAN-AMERICA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the prevention and treatment of pressure ulcers.
Device Description
The PressureGuard SelectCare is a powered air flotation mattress which provides pressure-reducing support within a range of adjustable firmness to meet individual comfort needs. The system also includes a CPR mode, providing a firm surface for performing CPR.
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K Number
K961502Device Name
LUBRICATING JELLY, LOW VISCOSITY
Manufacturer
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
1996-07-18
(90 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Applicant Name (Manufacturer) :
SPAN-AMERICA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Device Description
Lubricating Jelly is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
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K Number
K961159Device Name
POWERED LOW AIR LOSS MATTRESS SYSTEM
Manufacturer
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
1996-06-14
(84 days)
Product Code
FNM
Regulation Number
880.5550Why did this record match?
Applicant Name (Manufacturer) :
SPAN-AMERICA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pressure-reducing surface is indicated for the prevention and treatment of pressure ulcers.
Device Description
The Span-America Horizontal Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air sacks as a portion of the air is vented inside the mattress. The air flow is designed to provide and maintain an inflation level to achieve pressure reduction in the prevention and treatment of pressure ulcers.
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K Number
K960620Device Name
PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
Manufacturer
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
1996-04-25
(72 days)
Product Code
FNM
Regulation Number
880.5550Why did this record match?
Applicant Name (Manufacturer) :
SPAN-AMERICA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the prevention and treatment of pressure ulcers.
Device Description
The PressureGuard Low Air Loss Mattress System is a powered air flotation mattress which provides a continuous flow of air to the air cylinders as a portion of the air is vented inside the mattress. The air flow is designed to provide and maintain an inflation level to achieve pressure reduction in the prevention and treatment of pressure ulcers.
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K Number
K960189Device Name
GEL-T CUSHION
Manufacturer
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
1996-02-07
(22 days)
Product Code
KIC
Regulation Number
890.3175Why did this record match?
Applicant Name (Manufacturer) :
SPAN-AMERICA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954766Device Name
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
Manufacturer
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
1996-01-11
(86 days)
Product Code
FNM
Regulation Number
880.5550Why did this record match?
Applicant Name (Manufacturer) :
SPAN-AMERICA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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