510(k) K254216
K254216 is an FDA 510(k) premarket notification submitted by Hinge Health, Inc. for the device "Enso for Migraine". The FDA issued a decision of Substantially Equivalent on April 16, 2026. The device falls under product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine), a Class II device regulated under 21 CFR 882.5891. Hinge Health, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2026
- Date Received
- December 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- Device Class
- Class II
- Regulation Number
- 882.5891
- Review Panel
- NE
- Submission Type
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.