Data / Medical devices / South Korea / Nu Eyne Co., Ltd.
Nu Eyne Co., Ltd.: FDA-registered device maker in Guro-gu Seoul, South Korea, 5 510(k) clearances
Nu Eyne Co., Ltd. is registered with the FDA (registration 3015946733) in Guro-gu Seoul, South Korea. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015946733
- Address
- #608, 28, Digital-ro 30-gil, Guro-gu Seoul, South Korea, 08389
- Owner or operator
- Nu Eyne Co., Ltd. (10078817)
- Roles
- Manufacturer
- First device listed
- November 6, 2020
- Registered through
- 2026
- Brand names listed
- ADDNOX (Model: BPSPM1), ADDNOX Electrode (Model: PS-2HP2), Allive (Model: AL-2HP), Allive (Model: ALLIVE01), ELEXIR (Model: AL-2HP2), ELEXIR (Model: ALLIVE2), ELEXIR 2 (Model: ALLIVE3), ELEXIR Electrode (Model: PS-2HP2) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | PCC | 2 | Manufacturer | accessdata.fda.gov |
| Transcutaneous Nerve Stimulator For Adhd | QGL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 16, 2025 | K243289 | ADDNOX (BPSPM1) | QGL | Substantially Equivalent | Nu Eyne Co., Ltd. | accessdata.fda.gov |
| November 6, 2024 | K242719 | ELEXIR 2.0 (ALLIVE3) | PCC | Substantially Equivalent | Nu Eyne Co., Ltd. | accessdata.fda.gov |
| February 12, 2023 | K213629 | SMILE | QGL | Substantially Equivalent | Nu Eyne Co., Ltd. | accessdata.fda.gov |
| July 30, 2021 | K211380 | Elexir | PCC | Substantially Equivalent | Nu Eyne Co., Ltd. | accessdata.fda.gov |
| December 6, 2019 | K192773 | ALLIVE | PCC | Substantially Equivalent | Nu Eyne Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Transcutaneous Nerve Stimulator For Adhd
- All makers of Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Updated January 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.