FDA.reportPublic FDA data

CERAGEM Master S4

Primary DI
08809494001164
Brand
CERAGEM Master S4
Company
CERAGEM Co., Ltd.
Model
CGM MS-2302
Published
2025-03-07
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
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809494001164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809494001164088094940011648809494001164

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
Premarket exempt
true
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
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
08809494000006CERAGEM Master V3CGM MB-11012016-07-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
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