Cala Health, Inc. - FDA 510(k) Cleared Devices

Cala Health, Inc. develops wearable neuromodulation devices for tremor management. The company operates with a manufacturing facility in Burlingame, California. Cala's flagship technology delivers transcutaneous afferent patterned stimulation (TAPS) therapy to reduce hand tremor in patients with essential tremor and Parkinson's disease.

The company has received 6 FDA 510(k) clearances from 7 total submissions since its first clearance in 2018. All submissions focus on Neurology devices. The most recent clearance was in 2026, confirming active regulatory engagement and ongoing product development.

Cala's cleared devices include the Cala kIQ System and Cala Trio System, both designed for on-demand tremor relief. Clinical evidence supports consistent tremor reduction with relief lasting over 90 minutes per session. The devices are physician-prescribed and covered by Medicare for qualifying beneficiaries, as well as by the VA for veterans.

Explore the company's device names, product codes, and clearance dates in the full 510(k) database record.

510(k) submissions have been managed by Gardner Law Pllc as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.