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510(k) Data Aggregation
K Number
K130385Device Name
COMPRESSIBLE LIMB SLEEVE SYSTEM
Manufacturer
Date Cleared
2014-02-18
(368 days)
Product Code
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
MAXSTAR INDUSTRIAL CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UAM-8100 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
Compressible Limb Therapy System UAM-8100
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