HeadaTerm

GUDID 06971760280022

TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS deviceHeadaTerm enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort. The device could adhere to patients forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, and during ramping up, patients could choose comfortable intensity level by pressing the host key to lock up the current voltage, and the patient contact material is biocompatibility safe. The conductive paste could be replaced once the paste lost its adhesiveness and patients are recommended to replace the conductive paste after 7 times of treatment uses.

WAT Medical Technology Inc.

Craniofacial analgesia electrical stimulator

• Primary Device ID: 06971760280022
• NIH Device Record Key: 6caac499-61ae-4367-af56-486dbd916656
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeadaTerm
• Version Model Number: YF-HT-W1
• 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: false
• 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	06971760280022 [Primary]
GS1	16971760280029 [Package]; Package: box [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172450

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: 2021-12-08
• Device Publish Date: 2021-11-30

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