# K182706: External upper limb tremor stimulator

- Pathway: 510(k) (Special)
- Applicant: Cala Health, Inc.
- Decided: Oct 25, 2018 after 28 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: 1 generation back to DEN170028 (2018). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 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.

## Most influential descendants
- K203288: Cala Trio (2021), 5 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K182706
Methodology: https://510kreport.com/methodology