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Cala Health, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K243848
Cala kIQ
January 16, 2025
K242259
Cala kIQ
November 22, 2024
K222237
Cala kIQ
November 22, 2022
K203288
Cala Trio
October 5, 2021
K182706
External upper limb tremor stimulator
October 25, 2018
DEN170028
Cala ONE
April 26, 2018