510(k) Report

Devices descending from DEN170028

8 later devices reach Cala ONE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251517Encora X1Encora, Inc.20260—
+1K222237Cala kIQCala Health, Inc.20223—
+1K203288Cala TrioCala Health, Inc.20215—
+1K182706External upper limb tremor stimulatorCala Health, Inc.20187—
+2K250096Felix NeuroAI SystemFasikl Incorporated20250—
+2K242259Cala kIQCala Health, Inc.20242—
+3K243848Cala kIQCala Health, Inc.20251—
+4K253587Cala kIQ PlusCala Health, Inc.20260—