Data / Medical devices / United States / Fitbit LLC

Fitbit LLC: FDA-registered device maker in San Francisco, CA, United States, 6 510(k) clearances

Name: Fitbit LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fitbit LLC is registered with the FDA (registration 3009253624) in San Francisco, CA, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 25, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009253624
Address: 215 Fremont St, San Francisco, CA, United States, 94105
Owner or operator: Fitbit LLC (10040574)
Roles: Manufacturer
First device listed: July 30, 2014
Registered through: 2027
Brand names listed: Body Temperature Software, Fitbit Aria 2 WiFi Smart Scale, Fitbit Aria WiFi Smart Scale, Fitbit ECG App, Fitbit Irregular Rhythm Notifications, Google ECG App, Google Irregular Rhythm Notifications, Loss of Pulse Detection

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Body Composition	MNW	2	Manufacturer	accessdata.fda.gov
Analyzer, Body Composition, Exempt	PUH	2	Manufacturer	accessdata.fda.gov
Body Temperature Sensing Software	QZA	2	Manufacturer	accessdata.fda.gov
Electrocardiograph Software For Over-The-Counter Use	QDA	2	Manufacturer	accessdata.fda.gov
Loss Of Pulse Notification Software	SDY	2	Manufacturer	accessdata.fda.gov
Photoplethysmograph Analysis Software For Over-The-Counter Use	QDB	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
February 25, 2025	K242967	Loss of Pulse Detection	SDY	Substantially Equivalent	Fitbit	accessdata.fda.gov
February 13, 2025	K243778	Body Temperature Software (BTS)	QZA	Substantially Equivalent	Fitbit, LLC	accessdata.fda.gov
December 15, 2023	DEN230050	Body Temperature Software (BTS)	QZA	Unknown	Fitbit, LLC	accessdata.fda.gov
April 8, 2022	K212372	Fitbit Irregular Rhythm Notifications	QDB	Substantially Equivalent	Fitbit, Inc.	accessdata.fda.gov
September 11, 2020	K200948	Fitbit ECG App	QDA	Substantially Equivalent	Fitbit, Inc.	accessdata.fda.gov
June 2, 2014	K133872	ARIA WIFI SMART SCALE	MNW	Substantially Equivalent	Fitbit, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 25, 2025. 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.