Enso
Enso for Migraine is described as a wearable, app-controlled system that uses transcutaneous electrical nerve stimulation. It is indicated for adults 18 and older for acute migraine…
Enso for Migraine is described as a wearable, app-controlled system that uses transcutaneous electrical nerve stimulation.
It is indicated for adults 18 and older for acute migraine treatment with or without aura and for preventative treatment.
Listed Item
Transcutaneous Electrical Nerve Stimulator for Migraine Headaches
System Components
The system includes a TENS device, reusable and disposable hydrogel pads, a charging dock and accessories. The device attaches magnetically to a cradle on a pad placed on the skin.
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 | Hinge Health 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K254216 |
| Record published | 2026-04-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Enso for Migraine | 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 |
| AccuRelief | Drive DeVilbiss Healthcare | 1 |
| Elexir 2.0 | NU Eyne Co., Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254216 | 2026-04-16 |
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.