Data / Medical devices / United States / Cala Health, Inc.
Cala Health, Inc.: FDA-registered device maker in Foster City, CA, United States, 5 510(k) clearances
Cala Health, Inc. is registered with the FDA (registration 3011628389) in Foster City, CA, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated March 17, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011628389
- Address
- 1800 Gateway Drive Suite 120, Foster City, CA, United States, 94404
- Owner or operator
- Cala Health, Inc. (10061278)
- Roles
- Manufacturer
- First device listed
- December 9, 2022
- Registered through
- 2027
- Brand names listed
- Cala Trio, Cala kIQ, Cala kIQ Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| External Upper Limb Tremor Stimulator | QBC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 17, 2026 | K253587 | Cala kIQ Plus | QBC | Substantially Equivalent | Cala Health, Inc. | accessdata.fda.gov |
| January 16, 2025 | K243848 | Cala kIQ | QBC | Substantially Equivalent | Cala Health, Inc. | accessdata.fda.gov |
| November 22, 2024 | K242259 | Cala kIQ | QBC | Substantially Equivalent | Cala Health, Inc. | accessdata.fda.gov |
| November 22, 2022 | K222237 | Cala kIQ | QBC | Substantially Equivalent | Cala Health, Inc. | accessdata.fda.gov |
| October 5, 2021 | K203288 | Cala Trio | QBC | Substantially Equivalent | Cala Health, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.