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QBC

External Upper Limb Tremor Stimulator

Product code
QBC
Device name
External Upper Limb Tremor Stimulator
Device class
Class 2
21 CFR
21 CFR 882.5897
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
5
Summaries archived here
4 (direct download)
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-03-17.

NumberDecision dateApplicantDevice nameSummary
K2535872026-03-17Cala Health, Inc.Cala kIQ PlusPDF
K2515172026-02-05Encora, Inc.Encora X1PDF
K2500962025-07-01Fasikl IncorporatedFelix NeuroAI SystemPDF
K2438482025-01-16Cala Health, Inc.Cala kIQPDF
K2422592024-11-22Cala Health, Inc.Cala kIQFDA

4 summaries are archived here for direct download.

Official FDA classification page: QBC
Classification and pathway per current FDA publications. Data from openFDA (CC0).