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510(k) Data Aggregation
K Number
K060158Device Name
NET-2000 MICROCURRENT STIMULATOR
Manufacturer
Auri-Stem Medical Inc.
Date Cleared
2006-10-13
(266 days)
Product Code
QJQ, JXK
Regulation Number
882.5800Why did this record match?
Applicant Name (Manufacturer) :
Auri-Stem Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Application of electrical current to the head to treat insomnia, depression, or anxiety.
Device Description
The NET-2000 Microcurrent Stimulator is a precision electronic instrument used for the treatment of anxiety, depression, or insomnia. The treatment is simple and can easily be selfadministered. The device consists of a microprocessor controller box and skin contact electrodes. The small controller box is a software controlled low-intensity output. Current ranges from 0-600 microamperes typically set at 0.5 Hz. Additional frequencies at 1.5 and 100 Hz are available for the physician's use. The waveform is a bipolar asymmetric rectangular shape. Duty cycle is 50% with a 0 net current. Timed treatment is set at 16.5 minutes.
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