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K Number
K040065Device Name
JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES
Manufacturer
JACK SPEER AND ASSOC., INC.
Date Cleared
2004-03-29
(76 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
JACK SPEER AND ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Jack Speer and Associates, Inc. Huntleigh Reprocessed Compression Sleeve is recommended for use in patients for whom external compression the Huntleigh Flowtron® System is indicated for the prevention of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombus formation. Intraoperative compression therapy is frequently indicated, sometimes adjunctively with medical measures, during orthopedic, trauma, urologic and general surgery, particularly in patients over the age of 40.
Device Description
Huntleigh's compression sleeve device (CSD) is an SUD component of Huntleigh's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin with a bladder that is attached to a pneumatic compression device called a controller and it is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf (see diagrams in appendix 6). The sleeves are constructed with cells running the length of the patient's thigh or calf that are sequentially inflated and deflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.
The description of JSA's Reprocessed Compression Sleeves is substantially equivalent to the above described Huntleigh CSD. The primary descriptive difference between the two products is that JSA's Reprocessed Compression Sleeves have been reprocessed as several times and are labeled pasteurized and Huntleigh's CSD is a non-sterile product that has not been reprocessed.
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K Number
K031722Device Name
JSA REPROCESSED COMPRESSION SLEEVE DEVICES
Manufacturer
JACK SPEER AND ASSOC., INC.
Date Cleared
2003-11-25
(175 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
JACK SPEER AND ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices are designed to increase blood flow in the non-ambulatory patient in order to prevent deep vein thromboses or pulmonary embolism.
Device Description
The description of JSA's Reprocessed Compression Sleeves is substantially equivalent to the above described Kendall CSD. The primary descriptive difference between the two products is that JSA's Reprocessed Compression Sleeves have been reprocessed as many as eleven (11) times and are labeled pasteurized and Kendall product is a non-sterile product that has not been reprocessed. The studies summarized in section 9.0 Safety and Efficacy and the comparison tables in section 5 demonstrate that JSA's Reprocessed Compression Sleeves are substantially equivalent in physical, performance and safety characteristics to Kendall's CSDs.
Kendall's compression sleeve device (CSD) is an SUD and it is a component of Kendall's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin attached to a pneumatic compression device called a controller that is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf. The sleeves are constructed with a series of cells running the length of the patient's thigh or calf that are sequentially inflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.
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