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510(k) Data Aggregation
K Number
K062873Device Name
SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS
Manufacturer
E.C.I. USA CORPORATION
Date Cleared
2007-03-20
(176 days)
Product Code
DWL
Regulation Number
880.5780Why did this record match?
Applicant Name (Manufacturer) :
E.C.I. USA CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Helps to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
Device Description
The SunPolar Netex Medical Stockings which fall under the device classification of medical support stockings (21 CFR 880.5780). Both products are produced on circular knit machines and are made of nylon and spandex yarns. They provide similar compression at the ankle. This submission covers the indication that compression stockings in the 20-40mmHg range can help to prevent the pooling of blood in the legs and apply controlled pressure to the legs.
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