K251517

Encora X1

510(k) number
K251517
Device name
Encora X1
Applicant
Encora, Inc. MA · US
Product code
QBC — External Upper Limb Tremor Stimulator
Decision date
2026-02-05
Date received
2025-05-16
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K251517.pdf

Official FDA record: K251517
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.