FDA.reportPublic FDA data

LEBODY FORM

Primary DI
08809520340014
Brand
LEBODY FORM
Company
GTG Wellness Co., Ltd.
Model
Charger
Published
2023-03-17
Public version status
New
Distribution status
Not 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
08809520340014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809520340014088095203400148809520340014

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
689458057
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
08809520341004OLG-200OLG-200 FULLSET2023-03-17
08809520341011OLG-200FACE MASK2023-03-17
08809520341028OLG-200CONTROLLER2023-03-17
08809520341035OLG-100OLG-100 FULLSET2023-03-17
08809520341042OLG-100OLG-100 Face Mask2023-03-17
08809520341066OLG-100OLG-100 Neck2023-03-17
08809520341103OLZ-200OLZ-200 FULLSET2023-03-17
08809520341110OLZ-200OLZ-200 FACE MASK2023-03-17
08809520341134OMZ-100OMZ-100 FULLSET2023-03-17
08809520341141OMZ-100OMZ-100 FACE MASK2023-03-17
08809520341165OMZ-100OMZ-100 NECK2023-03-17
08809520341202LEBODY FORM FullSetLEBODY FORM FullSet2023-03-17
08809520341301LEF-100LEF-100 FullSet2023-03-17
08809520341400LEF-200LEF-200 FullSet2023-03-17
08809520341509WF-100WF-100 Fullset2023-03-17
08809520341608BBL-100BBL-100 FULLSET2023-03-17
08809520341707SNOR STOP PLUSSNOR STOP PLUS Fullset2023-03-17

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