FDA.reportPublic FDA data

CERAGEM Master V6

Primary DI
08809494000082
Brand
CERAGEM Master V6
Company
CERAGEM Co., Ltd.
Model
CGM MB-1701
Published
2021-03-31
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
IRPMassager, Powered Inflatable Tube
JFBTable, Physical Therapy, Multi Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2
JFBTable, Physical Therapy, Multi FunctionPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202937000
K220572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202937000Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd.2021-03-18JFB
K220572000Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd.2022-06-17JFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809494000082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809494000082088094940000828809494000082

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
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
00812120004895Game Ready* SystemAvanos Medical, Inc.IRP2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.IRP2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.IRP2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.IRP2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.IRP2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.IRP2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.IRP2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.IRP2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.IRP2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.IRP2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.IRP2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.IRP2026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.IRP2026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.IRP2026-07-31
00812120005380Game Ready* Hand/Wrist SleeveAvanos Medical, Inc.IRP2026-07-31