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510(k) K203419

Device
Relivion
Applicant
Neurolief , Ltd.
510(k) number
K203419
Product code
PCC
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-16
Date received
2020-11-19
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
Michal Kedar-Datel
Address
12 Giborei Israel St. Netanya IL 4250412 4250412

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K254216Enso for MigraineHinge Health, Inc.2026-04-16
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K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology2024-07-18
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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
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