Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702

Table, Physical Therapy, Multi Function

Ceragem Co, Ltd.

The following data is part of a premarket notification filed by Ceragem Co, Ltd. with the FDA for Ceragem Automatic Thermal Massager Model Cgm-mb-1701 & Cgm-mb-1702.

Pre-market Notification Details

Device IDK202937
510k NumberK202937
Device Name:Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
ClassificationTable, Physical Therapy, Multi Function
Applicant Ceragem Co, Ltd. 10, Jeongja 1-gil, Seonggeo-eup, Seobuk-gu Cheonan-si,  KR 31041
ContactHyeonggeun Hwang
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine,  CA  92620
Product CodeJFB  
CFR Regulation Number890.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2021-03-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809494000099 K202937 000
08809494000082 K202937 000

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