Elexir 2.0
ELEXIR 2.0 is an electrical nerve stimulator for acute migraine treatment and prevention of episodic migraine in adults aged 18 years and older. A self-adhesive electrode positions the…
ELEXIR 2.0 is an electrical nerve stimulator for acute migraine treatment and prevention of episodic migraine in adults aged 18 years and older. A self-adhesive electrode positions the device on the forehead over the upper branches of the trigeminal nerve on both sides.
The device passes electrical stimulation through the skin to these nerve branches. It has two fixed programs: Acute mode uses 100 Hz stimulation, while Prevention mode uses 60 Hz. The stimulation unit is powered by a rechargeable lithium-ion polymer battery.
Controls and Electrode
An on/off button lets the user stop the device. The unit includes a functioning indicator, a low-battery indicator and a timer. Its forehead electrode is self-adhesive.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| WAT Medical Technology Inc. | Ningbo | Zhejiang | Repacker / relabeller | 4 |
Record
| Listed by | NU Eyne Co., Ltd., South Korea |
|---|---|
| FDA product code | PCC |
| Device type | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5891 |
| Establishment | Manufacturer |
| 510(k) | K242719 |
| Record published | 2026-04-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 5 to 85 % RH; Storage environment temperature -10 to 45 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 5 to 85 % RH; Handling environment temperature 10 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ALLIVE3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cefaly® | Cefaly Technology Sprl | 14 |
| HeadaTerm | WAT Medical Technology Inc. | 3 |
| Relivion | Neurolief Inc. | 2 |
| Allive | NU Eyne Co., Ltd. | 1 |
| Elexir | NU Eyne Co., Ltd. | 1 |
| Relivion MG App | Neurolief Inc. | 1 |
| Tens 7000 | Drive DeVilbiss Healthcare | 1 |
| Doopang | Ybrain Inc. | 1 |
| Relivion MG PMI Physician Interface | Neurolief Inc. | 1 |
| Enso | Hinge Health Inc. | 1 |
| AccuRelief | Drive DeVilbiss Healthcare | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242719 | 2024-11-06 |
| K211380 | 2021-07-30 |
| K192773 | 2019-12-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.