Cleared Traditional

Cala kIQ

K222237 · Cala Health, Inc. · Neurology
Nov 2022
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K222237 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 November 22, 2022, 119 days after receiving the submission on July 26, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5897.

Submission Details

510(k) Number K222237 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2022
Decision Date November 22, 2022
Days to Decision 119 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.