Belifu

GUDID 06970389634988

Famidoc Technology Co.,Ltd.

Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use 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