LEBODY FORM

GUDID 08809520340014

GTG Wellness Co., Ltd.

Hand-held electric massager
Primary Device ID08809520340014
NIH Device Record Key16d62e6a-0443-46a5-9a62-ff12c214f85e
Commercial Distribution Discontinuation2023-03-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLEBODY FORM
Version Model NumberCharger
Company DUNS689458057
Company NameGTG Wellness Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809520340014 [Primary]

FDA Product Code

ISAMassager, Therapeutic, Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-27
Device Publish Date2023-03-17

Devices Manufactured by GTG Wellness Co., Ltd.

08809520340014 - LEBODY FORM2023-03-27
08809520340014 - LEBODY FORM2023-03-27
08809520341004 - OLG-2002023-03-27
08809520341011 - OLG-2002023-03-27
08809520341028 - OLG-2002023-03-27
08809520341035 - OLG-1002023-03-27
08809520341042 - OLG-1002023-03-27
08809520341066 - OLG-1002023-03-27
08809520341103 - OLZ-2002023-03-27

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