Cleared Traditional

K222237 - Cala kIQ (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K222237 · Cala Health, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
119d
Days
Class 2
Risk

K222237 is an FDA 510(k) clearance for the Cala kIQ. Classified as External Upper Limb Tremor Stimulator (product code QBC), Class II - Special Controls.

Submitted by Cala Health, Inc. (San Mateo, US). The FDA issued a Cleared decision on November 22, 2022 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5897 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cala Health, Inc. devices

Submission Details

510(k) Number K222237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 148d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QBC External Upper Limb Tremor Stimulator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05012579 Completed Interventional Industry-sponsored

Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor

A Study of Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Action Tremor in Parkinson's Disease (PD)

40
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Parkinson Disease
Study design Single group
Eligibility All sexes · 22 Years+
Sponsor Cala Health, Inc. (industry)
Started 2020-11-11 → Primary completion 2021-03-12
Primary outcome
Tremor Power
Secondary outcome
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
View full study on ClinicalTrials.gov

Regulatory Peers - QBC External Upper Limb Tremor Stimulator

All 8
Devices cleared under the same product code (QBC) and FDA review panel - the closest regulatory comparables to K222237.
Cala kIQ Plus
K253587 · Cala Health, Inc. · Mar 2026
Encora X1
K251517 · Encora, Inc. · Feb 2026
Felix NeuroAI System
K250096 · Fasikl Incorporated · Jul 2025
Cala kIQ
K243848 · Cala Health, Inc. · Jan 2025
Cala kIQ
K242259 · Cala Health, Inc. · Nov 2024
Cala Trio
K203288 · Cala Health, Inc. · Oct 2021