Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Hinge Health, Inc.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) 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. The listed applicant is Hinge Health, Inc.. The 510(k) number is K254216.

When did Enso for Migraine receive FDA 510(k) clearance?

Enso for Migraine received FDA 510(k) clearance on 2026-04-16, under 510(k) number K254216.

Who is the listed applicant for Enso for Migraine?

The FDA 510(k) record lists Hinge Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enso for Migraine?

The FDA product code for Enso for Migraine is PCC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07642414A Comprehensive Digital Care Program for Migraine ManagementRECRUITING

Other records listing Hinge Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233784ENSO (Model 2)

Related Devices (Code: PCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242719ELEXIR 2.0 (ALLIVE3)Nu Eyne Co., Ltd.K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly TechnologyK232749DOOPANGYbrain, Inc.K233751Milieve (YPS-301BD)Soterix Medical, Inc.K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc.K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxCefaly Technology

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.

↑