Medical Device Manufacturer · US , Burlingame , CA

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

7 submissions · 6 cleared · Since 2018

Official Website

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Cala Health, Inc. Neurology ✕

7 devices

1-7 of 7

Cleared CT Mar 17, 2026

Cleared CT Nov 22, 2022

External upper limb tremor stimulator

K182706 · QBC

Neurology · 28d

Not Cleared Apr 26, 2018

Cala ONE

DEN170028 · QBC

Neurology · 344d

Regulatory Intelligence

Linked clinical trials FDA-regulated device evidence

Regulatory consultant 510(k) submission support ecosystem

Gardner Law Pllc

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 10, 2026

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

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