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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K163550
Device Name Pobling MIITY 2
Applicant
HABALAN MED & BEAUTY CO.,LTD
907, 219, GASANDIGITAL 1-RO, GEUMCHEON-GU
SEOUL,  KR 08501
Applicant Contact RAY JEON
Correspondent
PLUS GLOBAL
300 ATWOOD
PITTSBURGH,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number882.5890
Classification Product Code
NFO  
Date Received12/19/2016
Decision Date 12/20/2017
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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