Relivion MG App
The Relivion MG App is an optional smartphone interface for reviewing information from the Relivion migraine treatment device. It displays device status, indications and alerts, and allows…
The Relivion MG App is an optional smartphone interface for reviewing information from the Relivion migraine treatment device. It displays device status, indications and alerts, and allows patients to report their migraine headache status for follow-up.
The app communicates with the headset over a low-energy Bluetooth connection. Treatment and device information can pass through the mobile application to the optional physician interface, enabling remote review of migraine attacks and treatments performed.
Listed Item
An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment to assist process management. It is not intended for control of equipment
Patient Management
The app and physician interface form the system’s optional Patient Management Interface. Treatment activation and stimulation intensity are controlled using the headset’s own controls. The app supports information review and reporting within the prescribed home-use system for adults.
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 | Neurolief Inc., United States |
|---|---|
| FDA product code | PCC |
| Device type | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5891 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K212106 |
| Record published | 2021-12-19 |
| Record revised | 2026-01-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RLV-PMI-102 | 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 |
| 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 |
| Elexir 2.0 | NU Eyne Co., Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212106 | 2021-08-02 |
| K203419 | 2021-02-16 |
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.