CERAGEM-C THERMAL ACUPRESSURE MASSAGER

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-c Thermal Acupressure Massager.

Pre-market Notification Details

Device IDK040031
510k NumberK040031
Device Name:CERAGEM-C THERMAL ACUPRESSURE MASSAGER
ClassificationTable, Physical Therapy, Multi Function
Applicant CERAGEM CO., LTD. 1800 MASSACHUSETTS AVE., NW SUITE 200 Washington,  DC  20036 -1221
ContactSuzan Onel
CorrespondentSuzan Onel
CERAGEM CO., LTD. 1800 MASSACHUSETTS AVE., NW SUITE 200 Washington,  DC  20036 -1221
Product CodeJFB  
CFR Regulation Number890.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-08
Decision Date2004-07-28
Summary:summary

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