FDA.reportPublic FDA data

HeadaTerm

Primary DI
16971760280005
Brand
HeadaTerm
Company
WAT Medical Technology Inc.
Model
YF-HT2
Device description
The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Published
2025-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K230782000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230782000TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc.2024-02-26PCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971760280005PackageGS130In Commercial Distribution
06971760280138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697176028000516971760280005
06971760280138069717602801386971760280138

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544509582
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
16971760280104EmeTermYF-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
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
06971760280022HeadaTermWAT Medical Technology Inc.PCC2021-11-30
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