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510(k) Data Aggregation
K Number
K133033Device Name
HIDREX PSP1000
Manufacturer
HIDREX GMBH
Date Cleared
2015-04-08
(559 days)
Product Code
EGJ
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
HIDREX GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Tap-Water-Iontophoresis device is intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered use and may have dangerous consequences.
Device Description
HIDREX iontophoresis devices are primarily intended for treating hyperhidrosis (excessive sweating) of hands and/or feet. Provided the optional axillary applicators are utilized, the system can also be used for treating axillary hyperhidrosis. The system consists of a control unit, power supply/safety wall adapter, and application accessories (treatment cover towel, treatment electrode, axillary sponge cushions). The control unit includes connection-jackets for accessories, control-buttons to choose the therapy-mode, a main display, and LED indicators. The device offers both DC and pulsed current output with adjustable pulse-width.
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