FDA.reportPublic FDA data

BON CHARGE

Primary DI
09361725000142
Brand
BON CHARGE
Company
BLUBLOX PTY LTD
Model
Cold & Heat Therapy Massage Gun
Published
2024-12-23
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
09361725000142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09361725000142093617250001429361725000142

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
745074558
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09361725000159BON CHARGEInfrared PEMF Sauna Dome2024-12-23
09361725000005BON CHARGEBullet Red Light Therapy Device2024-12-17
09361725000012BON CHARGEDemi Red Light Therapy Device2024-12-17
09361725000029BON CHARGEMax Red Light Therapy Device2024-12-17
09361725000036BON CHARGESuper Max Red Light Therapy Device2024-12-17
09361725000043BON CHARGERed Light Face Mask2024-12-17
09361725000050BON CHARGERed Light Neck and Chest Mask2024-12-17
09361725000067BON CHARGERed Light Therapy Blanket2024-12-17
09361725000074BON CHARGEMini Red Light Therapy Device2024-12-17
09361725000081BON CHARGERed Light Face Wand2024-12-17
09361725000098BON CHARGEPEMF Wrap2024-12-17
09361725000104BON CHARGEPEMF Mat Mini2024-12-17
09361725000111BON CHARGEPEMF Mat Demi2024-12-17
09361725000128BON CHARGEPEMF Mat Max2024-12-17
09361725000135BON CHARGESauna Blanket2024-12-17

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