ALLIVE
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 Allive.
Pre-market Notification Details
| Device ID | K192773 |
| 510k Number | K192773 |
| Device Name: | ALLIVE |
| Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Applicant | Nu Eyne Co., Ltd #403, Seoul Biohub, 117-3 Hoegi-ro, Dongdaemun-gu Seoul, KR 02455 |
| Contact | Dong Seong Lee |
| Correspondent | Dongha Lee KMC, Inc. Room No. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul, KR 08375 |
| Product Code | PCC |
| CFR Regulation Number | 882.5891 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-12-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800051500021 | K192773 | 000 |
Trademark Results [ALLIVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALLIVE 90499728 not registered Live/Pending |
Wentian Precision Technology Co., Ltd. 2021-01-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.