FDA.reportPublic FDA data

510(k) K242719

Device
ELEXIR 2.0 (ALLIVE3)
Applicant
Nu Eyne Co., Ltd.
510(k) number
K242719
Product code
PCC
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-06
Date received
2024-09-10
Regulation
882.5891
Classification name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dahee Kim
Address
#608, 28, Digital-Ro 30-Gil, Guro-Gu Seoul KR 08389 08389

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PCC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254216Enso for MigraineHinge Health, Inc.2026-04-16
K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology2024-07-18
K232749DOOPANGYbrain, Inc.2024-06-11
K233751Milieve (YPS-301BD)Soterix Medical, Inc.2024-06-03
K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc.2024-02-26
K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxCefaly Technology2022-12-13
K212106RelivionNeurolief , Ltd.2021-08-02
K211380ElexirNu Eyne Co., Ltd.2021-07-30
K210364Migraine Tens Digital Pain RelieverShenzhen Dongdixin Technology Co., Ltd.2021-06-17
K203419RelivionNeurolief , Ltd.2021-02-16
K201895Cefaly DualCefaly Technology2020-09-29
K192773ALLIVENu Eyne Co., Ltd.2019-12-06
K172450TENS device-HeadaTerm, eEspressWat Medical Technology (Ningbo) Co., Ltd.2018-09-13
K173006Cefaly DualCefaly Technology2017-11-28
K171446Cefaly AcuteCefaly Technology2017-09-15