K243848
- 510(k) number
- K243848
- Device name
- Cala kIQ
- Applicant
- Cala Health, Inc. CA · US
- Product code
- QBC — External Upper Limb Tremor Stimulator
- Decision date
- 2025-01-16
- Date received
- 2024-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243848.pdf
Official FDA record: K243848
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.