Cala kIQ Plus— 510(k) K253587
Substantially EquivalentCala Health, Inc.
FDA 510(k) clearance K253587 for Cala kIQ Plus, Substantially Equivalent on 2026-03-17. Applicant: Cala Health, Inc.. Device class: 2.
Summary
Cala Health's Cala kIQ Plus is filed under QBC, external upper limb tremor stimulators. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 882.5897. It was a Traditional 510(k), and Neurology is both the classification panel and the review panel.
Cala Health filed from San Mateo, California. The decision came 120 calendar days after FDA received it (November 17, 2025 to March 17, 2026).
Clearance details
- Applicant
- Cala Health, Inc.
- Product code
- Product code QBC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5897
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Mateo, CA, US
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