K254216
- 510(k) number
- K254216
- Device name
- Enso for Migraine
- Applicant
- Hinge Health, Inc. CA · US
- Product code
- PCC — Stimulator, Nerve, Electrical, Transcutaneous, For M
- Decision date
- 2026-04-16
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K254216.pdf
Official FDA record: K254216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.