Cala Health, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Cala kIQ Plus, Cala kIQ, Cala kIQ
7
Total
6
Cleared
1
Denied
FDA 510(k) Regulatory Record - Cala Health, Inc. Neurology ✕
7 devices
Cleared
CT
Mar 17, 2026
Cala kIQ Plus
Neurology
120d
Cleared
Jan 16, 2025
Cala kIQ
Neurology
31d
Cleared
Nov 22, 2024
Cala kIQ
Neurology
114d
Cleared
CT
Nov 22, 2022
Cala kIQ
Neurology
119d
Cleared
Oct 05, 2021
Cala Trio
Neurology
330d
Cleared
Oct 25, 2018
External upper limb tremor stimulator
Neurology
28d
Not Cleared
Apr 26, 2018
Cala ONE
Neurology
344d