LEF-100

GUDID 08809520341301

GTG Wellness Co., Ltd.

Hand-held electric massager

• Primary Device ID: 08809520341301
• NIH Device Record Key: 79669f38-ef50-409b-b318-26d525be3bf1
• Commercial Distribution Discontinuation: 2023-03-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LEF-100
• Version Model Number: LEF-100 FullSet
• Company DUNS: 689458057
• Company Name: GTG Wellness Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809520341301 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-27
• Device Publish Date: 2023-03-17

Devices Manufactured by GTG Wellness Co., Ltd.

• 08809520340014 - LEBODY FORM: 2023-03-27
• 08809520341004 - OLG-200: 2023-03-27
• 08809520341011 - OLG-200: 2023-03-27
• 08809520341028 - OLG-200: 2023-03-27
• 08809520341035 - OLG-100: 2023-03-27
• 08809520341042 - OLG-100: 2023-03-27
• 08809520341066 - OLG-100: 2023-03-27
• 08809520341103 - OLZ-200: 2023-03-27