Elexir
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Nu Eyne Co., Ltd.
The following data is part of a premarket notification filed by Nu Eyne Co., Ltd. with the FDA for Elexir.
Pre-market Notification Details
| Device ID | K211380 |
| 510k Number | K211380 |
| Device Name: | Elexir |
| Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Applicant | Nu Eyne Co., Ltd. #608, 28, Digital-ro 30-gil, Guro-gu Seoul, KR 08389 |
| Contact | Dong Seong Lee |
| Correspondent | Dong Seong Lee Nu Eyne Co., Ltd. #608, 28, Digital-ro 30-gil, Guro-gu Seoul, KR 08389 |
| Product Code | PCC |
| CFR Regulation Number | 882.5891 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-04 |
| Decision Date | 2021-07-30 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800051500199 | K211380 | 000 |
Trademark Results [Elexir]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELEXIR 98474297 not registered Live/Pending |
NU EYNE CO., LTD. 2024-03-29 |
 ELEXIR 90809386 not registered Live/Pending |
Core Pacific, Inc. 2021-07-02 |
 ELEXIR 87231618 5222998 Live/Registered |
Morae Legal Corporation 2016-11-09 |
 ELEXIR 73691960 1494050 Dead/Cancelled |
THIRD EYE SOFTWARE, INC. 1987-10-26 |
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