Loss of Pulse Detection FB612

GUDID 00810073612334

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.

Fitbit LLC

Loss-of-pulse emergency alert software

• Primary Device ID: 00810073612334
• NIH Device Record Key: 5d3d972e-bac5-4af2-a162-e3b46a915a45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Loss of Pulse Detection
• Version Model Number: FB612
• Catalog Number: FB612
• Company DUNS: 829454672
• Company Name: Fitbit LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810073612334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242967

FDA Product Code

• SDY: Loss Of Pulse Notification Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-24
• Device Publish Date: 2025-09-16

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• 00810073612334 - Loss of Pulse Detection: 2025-09-24 The Loss of Pulse detection SaMD is intended to be used for the detection of loss of pulse using photoplethysmography (PPG) and
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