HeadaTerm

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,…

Registry build 21.09.26

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.

3manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PCC
Manufacturer City Province Registered as Device types
JDI Electronics Factory Dongguan Guangdong Contract manufacturer 7
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
WAT Medical Technology Inc. Ningbo Zhejiang Repacker / relabeller 4

Record

Regulatory record for HeadaTerm
Listed by WAT Medical Technology Inc., China
FDA product code PCC
Device type Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device class Class 2
Regulation 21 CFR 882.5891
Establishment Repacker / relabeller, Manufacturer
510(k) K172450
Record published 2022-08-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, manufacturing date
Packaging Pack of 120, box of 120, box of 30

Catalogue Numbers

Catalogue numbers for HeadaTerm
Catalogue number Size Status
YF-HT-W1 In distribution
YF-HT-W1 In distribution
YF-HT2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cefaly® Cefaly Technology Sprl 14
Relivion Neurolief Inc. 2
Allive NU Eyne Co., Ltd. 1
Elexir NU Eyne Co., Ltd. 1
Relivion MG App Neurolief Inc. 1
Tens 7000 Drive DeVilbiss Healthcare 1
Doopang Ybrain Inc. 1
Relivion MG PMI Physician Interface Neurolief Inc. 1
Enso Hinge Health Inc. 1
AccuRelief Drive DeVilbiss Healthcare 1
Elexir 2.0 NU Eyne Co., Ltd. 1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K230782 2024-02-26

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer