The following data is part of a premarket notification filed by Neurolief Ltd. with the FDA for Relivion.
Device ID | K212106 |
510k Number | K212106 |
Device Name: | Relivion |
Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
Applicant | Neurolief Ltd. 12 Giborei Israel St. Netanya, IL 4250412 |
Contact | Michal Kedar-datel |
Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2320 Philadelphia, PA 19103 |
Product Code | PCC |
CFR Regulation Number | 882.5891 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-06 |
Decision Date | 2021-08-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17290018393014 | K212106 | 000 |
17290018393113 | K212106 | 000 |
07290018393147 | K212106 | 000 |
07290018393130 | K212106 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RELIVION 88005409 5823083 Live/Registered |
Neurolief Ltd. 2018-06-19 |