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510(k) Data Aggregation
K Number
K101906Device Name
SHAPE TO FIT COMPRESSION WEAR
Manufacturer
TSUNG HAU TECHNOLOGY CO., LTD.
Date Cleared
2010-09-17
(71 days)
Product Code
DWL
Regulation Number
880.5780Why did this record match?
Applicant Name (Manufacturer) :
TSUNG HAU TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Help prevent edema and leg discomfort, and help prevent deep vein thrombosis in individuals subjected to immobility.
Device Description
Shape to Fit Compression Socks and their substantial equivalents, mentioned above, are compression socks knitted by circular knit machines with nylon and spandex. They all include knee-high which are sized based on ankle and calf circumference fit. Shape to Fit Compression Socks provide controlled, uniform graduated compression, as is provided in all of these substantially equivalent products, starting with more compression circumferentially at the ankle at approximately 15 mmHg to 20 mmHg / 20 mmHg to 30 mmHg (based on average ankle size) then gradually decreases up to the proximal end.
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