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510(k) Data Aggregation
K Number
K031769Device Name
E-STRIP
Manufacturer
Date Cleared
2003-10-14
(127 days)
Product Code
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
EEMSO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The E-STRIP device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes.
Device Description
The E-STRIP is an active; self- contained Iontophoretic Drug Delivery System. An Integrated battery mechanism within the butterfly-designed soft electrode provides the E-STRIP with the capacity to deliver safe and complete iontophoresis therapy. The delivery rate of medicine is determined by applied voltage, skin resistance, and Conductivity of the medication/ saline solution.
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