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510(k) Data Aggregation
K Number
K120166Device Name
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
Manufacturer
WON INDUSTRIAL CO.
Date Cleared
2012-05-14
(116 days)
Product Code
IRP, CLA
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
WON INDUSTRIAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WIC -2008S is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.
Device Description
WIC-2008S is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.
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K Number
K102319Device Name
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
Manufacturer
WON INDUSTRIAL CO.
Date Cleared
2011-01-28
(164 days)
Product Code
IRP, CLA
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
WON INDUSTRIAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WIC-2008 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.
Device Description
WIC-2008 is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.
Ask a Question
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