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 IDK220572
510k NumberK220572
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 31045
ContactHyeonggeun Hwang
CorrespondentJoyce Kwon
Provision Consulting Group, Inc. 100 Barranca St. Suite 700 West Covina,  CA  91791
Product CodeJFB  
CFR Regulation Number890.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-06-17

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