# DEN170028: Cala ONE

- Pathway: De Novo (Direct)
- Applicant: Cala Health, Inc.
- Decided: Apr 26, 2018 after 344 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
No predicates in its family tree.
8 later devices descend from it; 4 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K182706: External upper limb tremor stimulator (2018), 7 descendants of its own
- 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

## 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/DEN170028
Methodology: https://510kreport.com/methodology