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510(k) K250266

Device
Ceragem Automatic Thermal Massager (CGM MB-2401)
Applicant
Ceragem Co., Ltd.
510(k) number
K250266
Product code
JFB
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-11
Date received
2025-01-30
Regulation
890.5880
Classification name
Table, Physical Therapy, Multi Function
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
Seon Gyu Choi
Address
10 Jeongja 1-Gil, Seonggeo-Eup Seobuk-Gu Cheonan-Si KR 31045 31045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JFB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)Marzzan Lucas Jorge2025-01-31
K243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)Ceragem Co., Ltd.2025-01-08
K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd.2024-11-27
K240168N7-SNuga Medical Co., Ltd.2024-09-12
K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd.2022-06-17
K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd.2021-03-18
K202113Ceragem Automatic Thermal Massager, Model CGM-MB-1901Ceragem Co., Ltd.2021-03-02
K153054N5-1Nuga Medical Co., Ltd.2016-02-05
K140592CERAGEM AUTOMATIC THERMAL MASSAGERCeragem International, Inc.2014-12-17
K111588LEGACY-500Mt Tables, LLC2012-10-26
K111941CHOYANG THERMAL MASSAGERChoyang Medical Instrument Co., Ltd.2012-05-25
K102938ACQPOINT THERMAJADE MASSAGE TABLEAcqpoint, Inc.2011-09-23
K111329NM-7000Nuga Medical Co., Ltd.2011-09-06
K102281THERMAL MASSAGE BED, MODEL 2D-GXInarex Corporation2010-12-22
K092731VIBRO-TRACPneumex, Inc.2010-06-10