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..
Clearance details
- Applicant
- Hinge Health, Inc.
- Product code
- Code PCC
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Adverse 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.