HeadaTerm

GUDID 16971760280005

The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

WAT Medical Technology Inc.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 16971760280005
• NIH Device Record Key: 90ff7509-1014-4fd3-8a3c-aed5a0496a4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeadaTerm
• Version Model Number: YF-HT2
• Company DUNS: 544509582
• Company Name: WAT Medical Technology Inc.
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	06971760280138 [Primary]
GS1	16971760280005 [Package]; Contains: 06971760280138; Package: Box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230782

FDA Product Code

• PCC: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

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: 2025-09-01
• Device Publish Date: 2025-08-22

On-Brand Devices [HeadaTerm]

• 06971760280022: TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impulses to act on th
• 16971760285000: TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impulses to act on th
• 16971760280005: The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in