Enso for Migraine— 510(k) K254216
Substantially EquivalentHinge Health, Inc.
FDA 510(k) clearance K254216 for Enso for Migraine, Substantially Equivalent on 2026-04-16. Applicant: Hinge Health, Inc.. Device class: 2.
Summary
Hinge Health's Enso for Migraine is filed under product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 882.5891. Neurology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Hinge Health filed from San Francisco, California. The record shows 108 calendar days from receipt to decision (December 29, 2025 to April 16, 2026).
Clearance details
- Applicant
- Hinge Health, Inc.
- Product code
- Product code PCC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5891
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code PCC
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view allAdverse events under product code PCC
product code PCC- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.