FITBIT LLC

FDA Device Registration & Listing · San Francisco, CA, US · Registration 3009253624

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
3009253624
FEI Number
3009253624
Entity Name
FITBIT LLC
City/State/Country
San Francisco, CA, US
Establishment Address
215 Fremont St, San Francisco, CA 94105, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Fitbit LLC (Owner Number: 10040574)
Owner / Operator Contact Address
215 Fremont Street, San Francisco, CA 94105, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212372
PMA Number
N/A

All Registered Proprietary Names

Fitbit Aria 2 WiFi Smart Scale Google ECG App Fitbit ECG App Fitbit Irregular Rhythm Notifications Google Irregular Rhythm Notifications

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QZA Body Temperature Sensing Software General Hospital Class 2 880.2915 2024-01-10
PUH Analyzer, Body Composition, Exempt Cardiovascular Class 2 870.2770 2017-10-05
QDA Electrocardiograph Software For Over-The-Counter Use Cardiovascular Class 2 870.2345 2020-09-21
QDB Photoplethysmograph Analysis Software For Over-The-Counter Use Cardiovascular Class 2 870.2790 2022-04-13

Official Correspondent

Jeanie Phan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fitbit LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243236 Whoop., Inc. WHOOP ECG (electrocardiogram) Feature (1.0) 2025-04-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009253624. Last updated year: 2026. Please use registration number 3009253624 when referencing this establishment in official correspondence.
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