FDA 510(k)

Cala kIQ

K-Number: K222237 · 2022-11-22

Decision Date2022-11-22

Product CodeQBC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Cala kIQ is the device name listed in this FDA 510(k) record. The listed applicant is Cala Health, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K222237. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cala kIQ?

Cala kIQ is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Cala Health, Inc.. The 510(k) number is K222237.

When did Cala kIQ receive FDA 510(k) clearance?

Cala kIQ received FDA 510(k) clearance on 2022-11-22, under 510(k) number K222237.

Who is the listed applicant for Cala kIQ?

The FDA 510(k) record lists Cala Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cala kIQ?

The FDA product code for Cala kIQ is QBC.

Other records listing Cala Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253587Cala kIQ Plus K243848Cala kIQ K242259Cala kIQ K203288Cala Trio K182706External upper limb tremor stimulator

Related Devices (Code: QBC)

K253587Cala kIQ PlusCala Health, Inc.K251517Encora X1Encora, Inc.K250096Felix NeuroAI SystemFasikl Incorporated K243848Cala kIQCala Health, Inc.K242259Cala kIQCala Health, Inc.K203288Cala TrioCala Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.