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510(k) Data Aggregation
K Number
K113275Device Name
COMPRESSIBLE LIMB THERAPY SYSTEM
Manufacturer
WONJINMULSAN CO., LTD.
Date Cleared
2012-02-27
(115 days)
Product Code
IRP, CLA
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
WONJINMULSAN CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated 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 injures, Postimmobilization edema, Venous insufficiencies, Lymphedema.
Device Description
Power Q1000 Premium 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. Power Q1000 Premium is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs.
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