FDA.reportPublic FDA data

CERAGEM Master V3

Primary DI
08809494000006
Brand
CERAGEM Master V3
Company
CERAGEM Co., Ltd.
Model
CGM MB-1101
Published
2016-07-29
Public version status
Update
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
K140592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140592000CERAGEM AUTOMATIC THERMAL MASSAGERCeragem International, Inc.2014-12-17JFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809494000006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809494000006088094940000068809494000006

GMDN Terms#

Term, Definition table
TermDefinition
Large-area electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.

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
08809643652476CERAGEM Master V5CGM MB-19022025-02-12
08809494000082CERAGEM Master V6CGM MB-17012021-03-31
08809494000099CERAGEM Master V6CGM MB-17022021-03-31
08809494000075CERAGEM Master V4CGM MB-19012021-03-12

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
08809643652476CERAGEM Master V5CERAGEM 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