Device
Transcutaneous Electrical Nerve Stimulator for Migraine Headaches
Manufacturer
Hinge Health, Inc.
Hinge Health, Inc.
Model: Enso for Migraine
DI: 00850045950149
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-24
Current Version: 2026-05-04
Description
Transcutaneous Electrical Nerve Stimulator for Migraine Headaches
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5ad7892e-0bb5-4dc4-96d2-a3012c62835e
Distribution Status:
In Commercial Distribution
DUNS Number:
080601423
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850045950149
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60682
Name: Craniofacial analgesia electrical stimulator
Definition:
A non-sterile, battery-powered device designed to non-invasively stimulate nerves of the head/face to prevent or treat headaches (including migraine) and/or frontal sinus pain; it may also be used to treat insomnia. It is a patient worn or hand-held device which typically consists of one or more electrodes designed to be placed on the forehead or other parts of the face, and a pulse generator to provide the electric current. The device is typically used by a patient in the home and the therapy may be referred to as neurostimulation or transcutaneous electrical stimulation (TENS). This is a reusable device.
FDA Product Codes
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Premarket Submissions
Submission Number:
K254216
Supplement Number:
000