FDA.reportPublic FDA data

Phantom Medical Care

Primary DI
08800123480404
Brand
Phantom Medical Care
Company
BODY FRIEND CO., LTD
Model
BFR-M8040US
Published
2022-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800123480404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800123480404088001234804048800123480404

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair electric massagerA mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688135736
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800123489001Phantom Neo, Medical PharaohBFR-M8900US2025-05-02
08800123480800Medical PhantomBFR-M8080US2023-12-10

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Primary DI, Brand, Company table
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