Cala kIQ— 510(k) K243848

Substantially Equivalent

Cala Health, Inc.

FDA 510(k) clearance K243848 for Cala kIQ, Substantially Equivalent on 2025-01-16. Applicant: Cala Health, Inc.. Device class: 2.

Clearance details

Applicant: Cala Health, Inc.
Product code: Code QBC
Device class: Class 2
Regulation: 21 CFR 882.5897
Advisory panel: Neurology
Date received: 2024-12-16
Decision date: 2025-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QBC

K253587 — Cala kIQ Plus2026-03-17
K251517 — Encora X12026-02-05
K250096 — Felix NeuroAI System2025-07-01
K242259 — Cala kIQ2024-11-22
K222237 — Cala kIQ2022-11-22

More clearances from Cala Health, Inc.

K203288 — Cala Trio2021-10-05
K182706 — External upper limb tremor stimulator2018-10-25
DEN170028 — Cala ONE2018-04-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.