K242259
- 510(k) number
- K242259
- Device name
- Cala kIQ
- Applicant
- Cala Health, Inc. CA · US
- Product code
- QBC — External Upper Limb Tremor Stimulator
- Decision date
- 2024-11-22
- Date received
- 2024-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K242259.pdf
Official FDA record: K242259
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.