K253587
- 510(k) number
- K253587
- Device name
- Cala kIQ Plus
- Applicant
- Cala Health, Inc. CA · US
- Product code
- QBC — External Upper Limb Tremor Stimulator
- Decision date
- 2026-03-17
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253587.pdf
Official FDA record: K253587
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.