FDA.reportPublic FDA data

Cefaly®

Primary DI
05425018850174
Brand
Cefaly®
Company
Cefaly Technology SPRL
Model
11301
Device description
CEFALY Enhanced Electrode Kit .3 electrodes
Published
2021-07-13
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

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425018850303PrimaryGS10
05425018850174Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425018850303054250188503035425018850303
05425018850174054250188501745425018850174

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(203) 309-5670info@cefaly.us

Regulatory Flags#

DUNS number
762450752
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
05425018850280Cefaly®CEFALY Enhanced 107012022-12-22
05425018850297Cefaly®CEFALY Connected 108012022-12-22
05425018850334Cefaly®CEFALY Connected Bundle VA108112022-12-22
05425018850303Cefaly®113012021-07-13
05425018850310Cefaly®113022021-07-13
05425018850181Cefaly®113022021-07-13
05425018850273Cefaly®CEFALY DUAL Enhanced106012021-05-17
05425018850266Cefaly®Prevent102302017-11-29
05425018850044Cefaly®111012016-09-17
05425018850105Cefaly®111062016-09-17
05425018850143Cefaly®112012016-09-17
05425018850150Cefaly®112022016-09-17
05425018850242Cefaly®Acute104052017-11-29
05425018850259Cefaly®Dual105052017-11-29
05425018850129Cefaly®102052016-09-17

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
06971760280022HeadaTermWAT Medical Technology Inc.PCC2021-11-30
05425018850303Cefaly®Cefaly Technology SPRLPCC2021-07-13
05425018850310Cefaly®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