Loss of Pulse Detection

Basic Information

• Brand Name: Loss of Pulse Detection
• Primary DI: 00810073612334
• Version / Model: FB612
• Catalog Number: FB612
• Company Name: Fitbit LLC
• Labeler DUNS: 829454672
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-16
• Public Version: 1
• Public Version Date: 2025-09-24
• Public Version Status: New
• Public Device Record Key: 5d3d972e-bac5-4af2-a162-e3b46a915a45

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 off by default.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SDY	Loss Of Pulse Notification Software	Cardiovascular	870.2790	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67417	Loss-of-pulse emergency alert software	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810073612334	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K242967	000