Cleared Special

Cala kIQ

K243848 · Cala Health, Inc. · Neurology
Jan 2025
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K243848 is an FDA 510(k) clearance for the Cala kIQ, a External Upper Limb Tremor Stimulator (Class II — Special Controls, product code QBC), submitted by Cala Health, Inc. (San Mateo, US). The FDA issued a Cleared decision on January 16, 2025, 31 days after receiving the submission on December 16, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5897.

Submission Details

510(k) Number K243848 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2024
Decision Date January 16, 2025
Days to Decision 31 days
Submission Type Special
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.