Cleared Traditional

Encora X1

K251517 · Encora, Inc. · Neurology
Feb 2026
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K251517 is an FDA 510(k) clearance for the Encora X1, a External Upper Limb Tremor Stimulator (Class II — Special Controls, product code QBC), submitted by Encora, Inc. (Boston, US). The FDA issued a Cleared decision on February 5, 2026, 265 days after receiving the submission on May 16, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5897.

Submission Details

510(k) Number K251517 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2025
Decision Date February 05, 2026
Days to Decision 265 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QBC — External Upper Limb Tremor Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5897
Definition An External Upper Limb Tremor Stimulator Is A Prescription Device Which Is Placed Externally On The Upper Limb And Designed To Aid In Tremor Symptom Relief Of The Upper Limb.