EQUATE

GUDID 06970389630898

TENS & EMS Pain Therapy Device

Famidoc Technology Co.,Ltd.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 06970389630898
• NIH Device Record Key: e2d4055b-ab0c-46fc-9887-67bd99e1b931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EQUATE
• Version Model Number: WMTTENS-150J
• Company DUNS: 421343701
• Company Name: Famidoc Technology Co.,Ltd.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	06970389630898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130723

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2025-03-12
• Device Publish Date: 2025-03-04

Devices Manufactured by Famidoc Technology Co.,Ltd.

• 06970389630348 - VeriSmart: 2025-07-01
• 06970389630898 - EQUATE: 2025-03-12TENS & EMS Pain Therapy Device
• 06970389630898 - EQUATE: 2025-03-12 TENS & EMS Pain Therapy Device
• 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