Cala Health, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253587Cala kIQ PlusMarch 17, 2026
K243848Cala kIQJanuary 16, 2025
K242259Cala kIQNovember 22, 2024
K222237Cala kIQNovember 22, 2022
K203288Cala TrioOctober 5, 2021
K182706External upper limb tremor stimulatorOctober 25, 2018
DEN170028Cala ONEApril 26, 2018