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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K122410
Device Name I RUNE (I-200L)
Original Applicant
821 samil plaza
837-26 yeuksam-dong
gangnam-gu,  KS 135-768
Original Contact yang ho dong
Regulation Number882.5890
Classification Product Code
Date Received09/11/2012
Decision Date 11/12/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No