# Cala Health, Inc.

- Location (FDA's records): San Mateo, CA
- FDA decisions: 7 (2018–2026): 6 510(k) clearances and 1 De Novo grant
- Product codes: QBC (7)
- Predicates its devices cite: 9 (9 its own); citations of its devices by later devices: 12 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Encora, Inc.: 2 (https://510kreport.com/company/encora)
- Fasikl Incorporated: 1 (https://510kreport.com/company/fasikl)

## Its most-cited devices
- DEN170028: Cala ONE (2018), cited by 4
- K182706: External upper limb tremor stimulator (2018), cited by 3
- K203288: Cala Trio (2021), cited by 2
- K242259: Cala kIQ (2024), cited by 1
- K243848: Cala kIQ (2025), cited by 1
- K222237: Cala kIQ (2022), cited by 1

## Recent decisions
- K253587: Cala kIQ Plus (Mar 17, 2026)
- K243848: Cala kIQ (Jan 16, 2025)
- K242259: Cala kIQ (Nov 22, 2024)
- K222237: Cala kIQ (Nov 22, 2022)
- K203288: Cala Trio (Oct 5, 2021)
- K182706: External upper limb tremor stimulator (Oct 25, 2018)
- DEN170028: Cala ONE (Apr 26, 2018)

Source page: https://510kreport.com/company/cala-health