Enso for Migraine
K-Number: K254216 · 2026-04-16
ApplicantHinge Health, Inc.
Decision Date2026-04-16
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Enso for Migraine is a medical device manufactured by Hinge Health, Inc.. It received FDA 510(k) clearance on 2026-04-16 under approval number K254216. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Enso for Migraine?
Enso for Migraine is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Hinge Health, Inc.. The 510(k) number is K254216.
When was Enso for Migraine approved by the FDA?
Enso for Migraine received FDA 510(k) clearance on 2026-04-16, under approval number K254216.
What company makes Enso for Migraine?
Enso for Migraine is manufactured by Hinge Health, Inc..
What is the FDA product code for Enso for Migraine?
The FDA product code for Enso for Migraine is PCC.
Other Devices by Hinge Health, Inc.
Related Devices (Code: PCC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.