FDA.reportPublic FDA data

CERAGEM Master V5

Primary DI
08809643652476
Brand
CERAGEM Master V5
Company
CERAGEM Co., Ltd.
Model
CGM MB-1902
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
JFBTable, Physical Therapy, Multi Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFBTable, Physical Therapy, Multi FunctionPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243355000Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd.2024-11-27JFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809643652476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809643652476088096436524768809643652476

GMDN Terms#

Term, Definition table
TermDefinition
Massage table/couch, line-poweredA mains electricity (AC-powered) table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table is electrically adjusted. It may incorporate a face hole (the patient's face fits into this when lying prone), a headrest, and an armrest(s). This device is typically known as a massage/therapy table, couch or bed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688326136
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809643652087CERAGEM Master V9CGM MB-24012025-07-15
08809494000747CERAGEM Master S4CGM MS-23012025-03-07
08809494001164CERAGEM Master S4CGM MS-23022025-03-07
08809494000686CERAGEM Master V7CGM MB-23012025-02-12
08809494000983CERAGEM Master V7CGM MB-23022025-02-12
08809494000082CERAGEM Master V6CGM MB-17012021-03-31
08809494000099CERAGEM Master V6CGM MB-17022021-03-31
08809494000075CERAGEM Master V4CGM MB-19012021-03-12
08809494000006CERAGEM Master V3CGM MB-11012016-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800091150620N motionNuga Medical Co.,Ltd.JFB2025-12-19
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.JFB2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.JFB2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.JFB2025-02-12
08800091150132NUGABESTNuga Medical Co.,Ltd.JFB2022-09-28
08809494000082CERAGEM Master V6CERAGEM Co., Ltd.JFB2021-03-31
08809494000099CERAGEM Master V6CERAGEM Co., Ltd.JFB2021-03-31
08809494000075CERAGEM Master V4CERAGEM Co., Ltd.JFB2021-03-12
00860001452525Air Flex with Auto-DistractionHILL LABORATORIES CO.JFB2020-02-04
B556HY7000U0MigunMIGUN LIFE CO., LTDJFB2017-05-01
B556HY7000UM0MigunMIGUN LIFE CO., LTDJFB2017-05-01
B344HY7000U0MigunMIGUN LIFE INCJFB2017-02-11
B344HY7000UM0MigunMIGUN LIFE INCJFB2016-09-19
08809494000006CERAGEM Master V3CERAGEM Co., Ltd.JFB2016-07-29