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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 K243644
Device Name Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
Applicant
Ceragem Co., Ltd.
10 Jeongja 1-Gil, Seonggeo-Eup
Seobuk-Gu
Cheonan-Si,  KR 31045
Applicant Contact Sangmin Lee
Correspondent
Provision Consulting Group, Inc.
13925 City Center Dr. Suite 200
Chino Hills,  CA  91709
Correspondent Contact Joyce Kwon
Regulation Number890.5880
Classification Product Code
JFB  
Subsequent Product Code
IRP  
Date Received11/26/2024
Decision Date 01/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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