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510(k) Data Aggregation
K Number
K042217Device Name
FLOWMEDIC, MODEL 220
Manufacturer
Date Cleared
2005-01-12
(149 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
FLOWMEDIC (ISRAEL) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FlowMedic™ FM220 System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.
Device Description
The FlowMedic™ FM220 System is a small, battery operated, microprocessor controlled, portable and simple mechanical system, intended for the improvement of blood circulation in the lower extremities through the application of intermittent compression to the calf.
The FlowMedic™ FM220 System consists of the following basic components:
1. FlowMedic™ FM220 System Control Unit and Straps
2. FlowMedic™ FM220 System Disposable Sleeve
3. Charger
The anatomical concave-convex shaped Control Unit is directly mounted on a pre-positioned Sleeve on the calf. Upon Control Unit activation, the straps are periodically pulled into the Control Unit base and subsequently pull the underneath sleeve, generating an intermittent compressive pressure on the patient's limb.
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