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510(k) Data Aggregation
K Number
K192749Device Name
Dermadry
Manufacturer
Dermadry Laboratories inc.
Date Cleared
2020-02-10
(133 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
Dermadry Laboratories inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dermadry is a Tap Water Iontophoresis device. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands, feet and underarms. Using the device in any other way than its intended purpose may be dangerous.
Device Description
The Dermadry is a tap water Iontophoresis device intended to treat hyperhidrosis of the hands, feet and underarms. It achieves its action by producing a given low level direct current (DC) level between each of the two applicable members being treated (i.e. the two feet, or the two hands, or the two underarms) for a given amount of time. The current is controlled and transmitted by a controller between two electrodes in separate water basins into which each of the hands or feet are placed, or via two electrodes within water soaked spongeous pockets that are placed in each of the underarms. It is for home use by a single patient (single patient). It is for use by prescription under the direction of a physician or clinician, and is intended for adult patients.
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