Hinge Health, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Enso for Migraine510(k)Apr 16, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 16, 2026
ENSO (Model 2)510(k)Feb 23, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 23, 2024