# K203288: Cala Trio

- Pathway: 510(k) (Traditional)
- Applicant: Cala Health, Inc.
- Decided: Oct 5, 2021 after 330 days
- Product code: QBC (External Upper Limb Tremor Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5897
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170028 (2018). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170028: Cala ONE, Cala Health, Inc. (2018) Summary page 4.
- K182706: External upper limb tremor stimulator, Cala Health, Inc. (2018) Summary page 3.

## Most influential descendants
- K222237: Cala kIQ (2022), 3 descendants of its own
- K242259: Cala kIQ (2024), 2 descendants of its own
- K243848: Cala kIQ (2025), 1 descendant of its own
- K253587: Cala kIQ Plus (2026), 0 descendants of its own
- K250096: Felix NeuroAI  System (2025), 0 descendants of its own

## Indications for use
The Cala Trio device is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.

Source page: https://510kreport.com/device/K203288
Methodology: https://510kreport.com/methodology