Belifu

GUDID 06970389634988

Famidoc Technology Co.,Ltd.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 06970389634988
• NIH Device Record Key: ef7dd0c7-86a8-4703-94c3-d4e8353d5fb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Belifu
• Version Model Number: FDES115
• Company DUNS: 421343701
• Company Name: Famidoc Technology Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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	06970389634988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130723

FDA Product Code

• IPF: Stimulator, Muscle, Powered

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: 2021-11-25
• Device Publish Date: 2021-11-17

Devices Manufactured by Famidoc Technology Co.,Ltd.

• 06970389631130 - Famidoc: 2023-10-02
• 06970389632335 - Famidoc: 2023-10-02
• 06970389634001 - Famidoc: 2023-10-02
• 06970389634025 - Famidoc: 2023-10-02
• 06970389634032 - Famidoc: 2023-10-02
• 06970389634056 - Famidoc: 2023-10-02
• 06970389634131 - Famidoc: 2023-10-02
• 06970389634155 - Famidoc: 2023-10-02