Cleared Traditional

Cala Trio

K203288 · Cala Health, Inc. · Neurology
Oct 2021
Decision
330d
Days
Class 2
Risk

About This 510(k) Submission

K203288 is an FDA 510(k) clearance for the Cala Trio, a External Upper Limb Tremor Stimulator (Class II — Special Controls, product code QBC), submitted by Cala Health, Inc. (Burlingame, US). The FDA issued a Cleared decision on October 5, 2021, 330 days after receiving the submission on November 9, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5897.

Submission Details

510(k) Number K203288 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2020
Decision Date October 05, 2021
Days to Decision 330 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.