CALA HEALTH, INC.

FDA Device Registration & Listing · Foster City, CA, US · Registration 3011628389

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011628389
FEI Number
3011628389
Entity Name
CALA HEALTH, INC.
City/State/Country
Foster City, CA, US
Establishment Address
1800 Gateway Drive Suite 120, Foster City, CA 94404, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Cala Health, Inc. (Owner Number: 10061278)
Owner / Operator Contact Address
1800 Gateway Drive Suite 120, San Mateo, CA 94404, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222237
PMA Number
N/A

All Registered Proprietary Names

Cala Trio Cala kIQ Cala kIQ Plus Cala kIQ

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QBC External Upper Limb Tremor Stimulator Neurology Class 2 882.5897 2022-12-09
QBC External Upper Limb Tremor Stimulator Neurology Class 2 882.5897 2024-12-13
QBC External Upper Limb Tremor Stimulator Neurology Class 2 882.5897 2026-04-06
QBC External Upper Limb Tremor Stimulator Neurology Class 2 882.5897 2022-12-09

Official Correspondent

Regulatory Affairs Cala Health

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cala Health, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011628389. Last updated year: 2026. Please use registration number 3011628389 when referencing this establishment in official correspondence.
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