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510(k) Data Aggregation
K Number
K061411Device Name
TORBOT VASCULAR COMPRESSION GARMENTS
Manufacturer
TORBUT GROUP, INC.
Date Cleared
2006-10-18
(149 days)
Product Code
DWL
Regulation Number
880.5780Why did this record match?
Applicant Name (Manufacturer) :
TORBUT GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Torbot Vascular Compression Garments are intended to be used to apply pressure to the extremity and are indicated for use in the management of pooling of blood and/or lymphedema.
Device Description
Torbot Vascular Compression Garments, custom and ready-to-wear, help to prevent pooling of blood and fluid in the extremities by applying controlled graduated pressure. The fabric used is comprised of nylon and spandex which is used in the predicate devices.
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