Loss of Pulse Detection

Primary DI
00810073612334
Brand
Loss of Pulse Detection
Company
Fitbit LLC
Model
FB612
Catalog number
FB612
Device description
The Loss of Pulse detection SaMD is intended to be used for the detection of loss of pulse using photoplethysmography (PPG) and accelerometer sensors present in a wrist worn consumer wearable device. Upon detection of loss of pulse, when the smartwatch is worn, the feature will prompt haptic and audio alerts and notifications to the user and prompt the user’s compatible hardware to call emergency services if the user is unresponsive to the notifications and alerts. This is an opt-in feature and will be offby default.
Published
2025-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SDYLoss Of Pulse Notification Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDYLoss Of Pulse Notification SoftwareCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242967000Loss of Pulse DetectionFitbit2025-02-25SDY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810073612334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810073612334008100736123348100736123340810073612334

GMDN Terms#

Term, Definition table
TermDefinition
Loss-of-pulse emergency alert softwareA software program intended to be installed on a wearable off-the-shelf smart device with photoplethysmography (PPG) capacities [e.g., smart watch] to recognise the absence of a pulse and notify the wearer with audio, visual or haptic alerts; in the absence of a response from the wearer the software is designed to contact emergency medical services (EMS). It is not intended for real-time patient monitoring.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877) 623-4997support@fitbit.com

Regulatory Flags#

DUNS number
829454672
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028737778Google Irregular Rhythm NotificationsGA13099 2026-05-20
00810028737815Google ECG AppGA130982026-05-20
00810038852720 Fitbit Irregular Rhythm NotificationsFB604FB6042022-04-25
00810038851983Fitbit ECG AppFB6032020-10-07
00810073612327Body Temperature Sensing SoftwareFB611FB6112025-09-16
00898628002038AriaFB201WFB201W2016-10-21
00898628002045AriaFB201BFB201B2016-10-21
00816137020800Aria 2 Wi-Fi Smart Scale FB202FB202BK2017-10-25
00816137020831Aria 2 Wi-Fi Smart Scale FB202 FB202WT2017-10-25
00810351028895AriaFB201B2FB201B22016-10-21