FDA.reportPublic FDA data

CALA HEALTH, INC.

Matched from indexed company URL: Cala Health, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116283893011628389CALA HEALTH, INC.1N2026-01-011800 Gateway Drive Suite 120 Foster City CA US 94404

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851749007474Cala kIQ - Cala kIQ Band, Large888-699-1009customercare@calahealth.com
00851749007481Cala kIQ - Cala kIQ Band, Medium888-699-1009customercare@calahealth.com
00851749007498Cala kIQ - Cala kIQ Band, Small888-699-1009customercare@calahealth.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2335651329928776K253587Cala kIQ PlusQBC2026-03-17
2335651788808236K243848Cala kIQQBC2025-01-16
2335651793015527K242259Cala kIQQBC2024-11-22
2335651959879888K222237Cala kIQQBC2022-11-22
2335651689955137K203288Cala TrioQBC2021-10-05
2335651286823923DEN170028Cala ONEQBC2018-04-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QBC62026-03-17

PMN#

GUDID#