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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name table, physical therapy, multi function
510(k) Number K202113
Device Name Ceragem Automatic Thermal Massager, Model CGM-MB-1901
Ceragem Co, Ltd.
10, Jeongja 1-Gil, Seonggeo-Eup, Seobuk-Gu
cheonan-si,  KR 31041
Applicant Contact hyeonggeun hwang
LK Consulting Group USA, Inc.
1150 Roosevelt, STE 200
irvine,  CA  92620
Correspondent Contact priscilla chung
Regulation Number890.5880
Classification Product Code
Date Received07/30/2020
Decision Date 03/02/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No