# K253587: Cala kIQ Plus

- Pathway: 510(k) (Traditional)
- Applicant: Cala Health, Inc.
- Decided: Mar 17, 2026 after 120 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: 6 generations back to DEN170028 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243848: Cala kIQ, Cala Health, Inc. (2025) Summary page 5.

## Indications for use
Cala kIQ Plus is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor. Cala kIQ Plus is indicated to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson’s disease.

Source page: https://510kreport.com/device/K253587
Methodology: https://510kreport.com/methodology