FDA.reportPublic FDA data

HeadaTerm

Primary DI
06971760280022
Brand
HeadaTerm
Company
WAT Medical Technology Inc.
Model
YF-HT-W1
Device description
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.
Published
2021-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCCStimulator, Nerve, Electrical, Transcutaneous, For MigraineNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172450000TENS device-HeadaTerm, eEspressWat Medical Technology (Ningbo) Co., Ltd.2018-09-13PCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971760280029PackageGS1120In Commercial Distribution
06971760280022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697176028002916971760280029
06971760280022069717602800226971760280022

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial analgesia electrical stimulatorA non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544509582
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971760281487EmeTermYF-ZTY-E22026-04-23
06971760281470EmeTermYF-ZTY-E12026-04-14
06971760281357EmeTermYF-ZTY-E12026-01-23
06971760280787EmeTermYF-ZTY-E12025-08-22
06971760280800EmeTermYF-ZTY-E12025-08-22
06971760280824EmeTermYF-ZTY-E12025-08-22
06971760280848EmeTermYF-ZTY-E12025-08-22
06971760281074EmeTermYF-ZTY-E12025-07-31
06971760281081EmeTermYF-ZTY-E12022-08-23
06971760280251EmeTermYF-ZTY-E12025-07-31
06971760280138HeadaTermYF-HT22025-08-22
06971760280305EmeTermYF-ZTY-E22025-08-22
06971760280367EmeTermYF-ZTY-E12025-08-22
06971760281128EmeTermYF-ZTY-E12025-08-22
16971760280005HeadaTermYF-HT22025-08-22
16971760280050EmeTermYF-ZTY-E22025-08-22
16971760280067EmeTermYF-ZTY-E12025-08-22
16971760280074EmeTermYF-ZTY-E12025-08-22
16971760280081EmeTermYF-ZTY-E12025-08-22
16971760280098EmeTermYF-ZTY-E12025-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800051500502ELEXIR 2.0Nu Eyne Co., Ltd.PCC2026-04-27
00850045950149EnsoHinge Health, Inc.PCC2026-04-24
08800020403032DOOPANGYbrain Inc.PCC2026-03-10
06971760280138HeadaTermWAT Medical Technology Inc.PCC2025-08-22
16971760280005HeadaTermWAT Medical Technology Inc.PCC2025-08-22
00023601261007AccuReliefDrive Devilbiss HealthcarePCC2024-12-17
30023601261008AccuReliefCOMPASS HEALTH BRANDS CORP.PCC2024-12-17
00092237626658TENS 7000Drive Devilbiss HealthcarePCC2024-10-30
30092237626659TENS 7000COMPASS HEALTH BRANDS CORP.PCC2024-10-30
08800051500199ELEXIRNu Eyne Co., Ltd.PCC2023-08-04
05425018850280Cefaly®Cefaly Technology SPRLPCC2022-12-22
05425018850297Cefaly®Cefaly Technology SPRLPCC2022-12-22
05425018850334Cefaly®Cefaly Technology SPRLPCC2022-12-22
06971760285003HeadaTermWAT Medical Technology Inc.PCC2022-08-23
16971760285000HeadaTermWAT Medical Technology Inc.PCC2022-08-23
07290018393130Relivion MG PMI Physician InterfaceNEUROLIEF LTDPCC2021-12-19
07290018393147Relivion MG AppNEUROLIEF LTDPCC2021-12-19
07290018393000RelivionNEUROLIEF LTDPCC2021-12-05
07290018393017RelivionNEUROLIEF LTDPCC2021-12-05
17290018393113RelivionNEUROLIEF LTDPCC2021-12-05
17290018393014RelivionNEUROLIEF LTDPCC2021-12-05
05425018850303Cefaly®Cefaly Technology SPRLPCC2021-07-13
05425018850310Cefaly®Cefaly Technology SPRLPCC2021-07-13
05425018850174Cefaly®Cefaly Technology SPRLPCC2021-07-13
05425018850181Cefaly®Cefaly Technology SPRLPCC2021-07-13
05425018850273Cefaly®Cefaly Technology SPRLPCC2021-05-17
08800051500021ALLIVENu Eyne Co., Ltd.PCC2021-03-22
05425018850266Cefaly®Cefaly Technology SPRLPCC2017-11-29
05425018850242Cefaly®Cefaly Technology SPRLPCC2017-11-29
05425018850259Cefaly®Cefaly Technology SPRLPCC2017-11-29