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510(k) Data Aggregation
K Number
K101087Device Name
REPROCESSED RESTEP COMPRESSION SLEEVES
Manufacturer
Date Cleared
2010-07-16
(88 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
ASCENT HEATLHCARE SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.
Device Description
The Restep Deep Vein Thrombosis (DVT) System, consists of the Restep pump and compatible leg and foot compression garments. The system is a lightweight, portable, prescriptive pneumatic compression device that helps to stimulate blood flow in the deep veins of the legs through the use of pneumatically controlled single chamber pressure cuffs, actuated by an electronically controlled pump unit and solenoid valves.
Note: Only the compression sleeves (garments) are the subject of this submission, the pump is not included in the scope of this submission.
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