I RUNE (I-200L)


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

Correspodent Contact yang ho dong
Regulation Number 882.5890
Classification Product Code
NUH  
Date Received 08/08/2012
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