FDA.reportPublic FDA data

Cefaly®

Primary DI
05425018850297
Brand
Cefaly®
Company
Cefaly Technology SPRL
Model
CEFALY Connected
Catalog number
10801
Device description
CEFALY Connected is indicated to be used for:Acute treatment of migraine with or without aura in patients 18 years of age or older.Preventative treatment of migraine in patients 18 years of age or older.
Published
2022-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212071000Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxCefaly Technology2022-12-13PCC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425018850297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425018850297054250188502975425018850297

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
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity45 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature23 Degrees Fahrenheit95 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-844-475-7100info@cefaly.us

Regulatory Flags#

DUNS number
762450752
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05425018850280Cefaly®CEFALY Enhanced 107012022-12-22
05425018850334Cefaly®CEFALY Connected Bundle VA108112022-12-22
05425018850303Cefaly®113012021-07-13
05425018850310Cefaly®113022021-07-13
05425018850174Cefaly®113012021-07-13
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
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