# K254216: Enso for Migraine

- Pathway: 510(k) (Traditional)
- Applicant: Hinge Health, Inc.
- Decided: Apr 16, 2026 after 108 days
- Product code: PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine)
- Device class: 2
- Regulation: 21 CFR 882.5891
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN120019 (2014). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234029: CEFALY Connected - OTC, CEFALY Connected - Rx, Cefaly Technology (2024) Summary page 5.

## Indications for use
Enso for Migraine is indicated for patients 18 years of age or older for acute treatment of migraine with or without aura and preventative treatment of migraine. Enso for Migraine is for patients diagnosed with migraine by a physician.

Source page: https://510kreport.com/device/K254216
Methodology: https://510kreport.com/methodology