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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)
Applicant
MEDIRUNE CO, LTD
821 SAMIL PLAZA
837-26 YEUKSAM-DONG
GANGNAM-GU,  KR 135-768
Applicant Contact YANG HO DONG
Correspondent
MEDIRUNE CO, LTD
821 SAMIL PLAZA
837-26 YEUKSAM-DONG
GANGNAM-GU,  KR 135-768
Correspondent Contact YANG HO DONG
Regulation Number882.5890
Classification Product Code
NUH  
Date Received08/08/2012
Decision Date 11/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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