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Fitbit, Inc.

USA · San Francisco

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 0Class II 6Class III 0

plus 7 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 6 510(k), 0 PMA

Manufacturer names merged into this page: FITBIT LLC

FDA 510(k) clearances by year

12014 · K133872

12020 · K200948

12022 · K212372

12023 · DEN230050

22025 · K242967

FDA listed device types

Loss Of Pulse Notification Software 1Analyzer, Body Composition, Exempt 1Photoplethysmograph Analysis Software For Over-The-Counter Use 1Body Temperature Sensing Software 1Electrocardiograph Software For Over-The-Counter Use 1Analyzer, Body Composition 1

Market	Identifier	Name	Class / date
US	K242967	Loss of Pulse Detection	2025-02-25
US	K243778	Body Temperature Software (BTS)	2025-02-13
US	DEN230050	Body Temperature Software (BTS)	2023-12-15

Fitbit, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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