Relivion

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Neurolief Ltd.

The following data is part of a premarket notification filed by Neurolief Ltd. with the FDA for Relivion.

Pre-market Notification Details

Device IDK212106
510k NumberK212106
Device Name:Relivion
ClassificationStimulator, Nerve, Electrical, Transcutaneous, For Migraine
Applicant Neurolief Ltd. 12 Giborei Israel St. Netanya,  IL 4250412
ContactMichal Kedar-datel
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street, Suite 2320 Philadelphia,  PA  19103
Product CodePCC  
CFR Regulation Number882.5891 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-06
Decision Date2021-08-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290018393014 K212106 000
17290018393113 K212106 000
07290018393147 K212106 000
07290018393130 K212106 000

Trademark Results [Relivion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RELIVION
RELIVION
88005409 5823083 Live/Registered
Neurolief Ltd.
2018-06-19

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