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510(k) Data Aggregation
K Number
K071040Device Name
WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS
Manufacturer
Date Cleared
2007-05-22
(40 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
WRIGHT LINEAR PUMP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Wright 51 and 52 Sequential Compression System is for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
Device Description
The Wright 51 and 52 Sequential Compression System consists of a sequential, segmental, intermittent, pneumatic compression pump and appropriate limb appliances. It is typically used to compress an upper or lower body extremity.
The pump consists of an enclosure that contains a small air compressor, solenoid valves, printed circuit board including a programmable microprocessor, graphic display, and associated electronic circuits and pneumatic connections. Software controls the sequential opening and closing of the solenoid valves, which are connected to five (5) external pressure ports. The pressure ports are connected to the limb appliance through a hose assembly.
The inflatable limb appliance is made of fabric and may comprise from one to five cells, with the length of the appliance dependent upon the physician's order or patients limb length. In operation, the pump fills the inflatable limb appliance with air, to prescribed, preset pressures -- each cell in sequence. This simple repetition of the sequence of compression and exhaust improves return blood circulation for the patient.
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K Number
K961292Device Name
WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
Manufacturer
Date Cleared
1996-11-06
(216 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
WRIGHT LINEAR PUMP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.
Device Description
This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to sequentially inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 15 lbs.
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K Number
K961797Device Name
WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE
Manufacturer
Date Cleared
1996-11-06
(181 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
WRIGHT LINEAR PUMP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders. Complies with physician-prescribed treatment pressures.
Device Description
This is an electromechanical pneumatic device that employs a compressor and precision timers, regulators, and gages to sequentially inflate a sleeve appliance that fits over the patient's extremity. This unit delivers a calibrated gradient pressure. The device is approximately 10"W x 6.75"H x 5.6"D and weighs less than 15 Ibs.
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K Number
K961891Device Name
WLP SINGLE-SEGMENT VERSION WLP SOLO VII
Manufacturer
Date Cleared
1996-11-06
(181 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
WRIGHT LINEAR PUMP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.
Device Description
This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 13 Ibs.
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