Fitbit (Charge / Sense / Versa)

[commercial]

biometric · food-service · 1 deployments in catalog

Field Advisory

FDA clearances: ECG app: FDA-cleared Sept 2020 (on-demand 30-sec ECG, AFib vs sinus rhythm; on Sense/Sense 2). PPG Irregular Heart Rhythm Notifications (passive background AFib detection): FDA-cleared Apr 11 2022 (Charge 5/6, Sense/Sense 2, Versa 3/4, Inspire 3, Luxe, Pixel Watch)., CAP-FLAG: SpO2, EDA 'stress', Sleep Score, Daily Readiness are WELLNESS features, NOT FDA-cleared for any diagnostic claim., Current state (corrects 'dead' framing): Fitbit is now a Google PRODUCT LINE, not an independent company (register under Google ownership). Standalone Fitbit-branded SMARTWATCH hardware is deprioritized (no Sense 3; strategy consolidated onto Pixel Watch), BUT Google confirmed (Oct 2025) new Fitbit hardware for 2026 (trackers) + a 'Fitbit Coach' AI - so deprioritized, not dead., Verification posture: Boundary: biometric-primary + AI-augmented. Clinical posture: strongest of the cohort on AFib specifically (Fitbit Heart Study, large prospective, published 2025). NOT verified: 2026 Fitbit hardware specs (unannounced); 'Fitbit Coach' AI (pre-launch).

Manufacturer

Fitbit

Form Factor

biometric

Lifecycle

commercial

Operational Reality

Audited

Deployments

1

Target Price

$110 (actual sale price)

  • COMMERCIAL

Description

Fitbit, founded in 2007 by James Park and Eric Friedman and acquired by Google in a roughly $2.1 billion deal that closed in January 2021, is now a Google product line rather than an independent company, and its devices are biometric-primary fitness bands and watches with atrial-fibrillation AI augmentation. Its current and last-generation devices include the Charge 6 from 2023, the Sense 2, and the Versa 4, carrying optical heart-rate sensing, ECG electrodes on the Sense line, a continuous electrodermal stress sensor on the Sense 2, blood oxygen, and skin temperature, plus Sleep Score, Sleep Profile, a Daily Readiness Score, and stress management. Its FDA clearances are the ECG app, cleared in September 2020 for on-demand assessment of atrial fibrillation versus sinus rhythm, and passive PPG-based Irregular Heart Rhythm Notifications, cleared on April 11, 2022 across a broad device range. Its blood oxygen, electrodermal stress, Sleep Score, and Daily Readiness features are wellness-grade and not FDA-cleared for any diagnostic claim. On current state, while standalone Fitbit-branded smartwatch hardware has been deprioritized with no Sense 3 and the smartwatch strategy consolidated onto the Pixel Watch, Google confirmed in October 2025 that new Fitbit hardware, expected to be trackers, is coming in 2026 along with a Fitbit Coach AI feature, so the line is deprioritized rather than dead. Its clinical-validation posture is the strongest in the cohort specifically on atrial fibrillation, anchored by the large prospective Fitbit Heart Study, while the 2026 Fitbit hardware specifications and the Fitbit Coach AI capabilities are unannounced and not verified.

Key facts & specs

19 entries
website
https://www.fda.gov/medical-devices/recently-approved-devices/fitbit-sense-ecg-k203204;
maturity
commercial
lifecycle
active
manufacturer
Fitbit
deployments count
1
Maturity stage
commercial
Specs
Fitbit (Charge 6 (2023), Sense 2, Versa 4 - current/last-gen). Sensors: optical HR/PPG, ECG electrodes (Sense/Sense 2), cEDA stress sensor (Sense 2), SpO2, skin temperature. AI/health: AFib/ECG, Sleep Score + Sleep Profile, Daily Readiness Score, stress management. Founded 2007 (James Park + Eric Friedman); acquired by Google, closed Jan 2021 (~$2.1B). Hardware purchase + optional Fitbit Premium (~$9.99/mo).
Battery
7 days
Weight kg
0.005
Form Factor
biometric (biometric-primary fitness band/watch + AI augmentation; AFib/ECG cleared)
Fda clearance
Source: https://www.fda.gov/medical-devices/recently-approved-devices/fitbit-sense-ecg-k203204; Status: cleared; Details: Fitbit Sense: FDA-cleared ECG (K203204, 2020); irregular rhythm notification. Post-Google acquisition (2021) maintains clearance. Charge/Versa lines = wellness only.; Audited at: 2026-06-07; Source name: FDA; Health claim: ECG on Sense model only; wellness/fitness primary for Charge/Versa. FDA-cleared subset is model-specific.; Verification posture: verified
Acquisition price
~$2.1 billion
F D A clearances
ECG app cleared Sept 2020; PPG Irregular Heart Rhythm Notifications cleared Apr 11 2022
Sensor suite
Optical HR/PPG, ECG electrodes (Sense/Sense 2), cEDA stress sensor (Sense 2), SpO2, skin temperature
Subscription price
Fitbit Premium ~$9.99/mo
Current models
Charge 6 (2023), Sense 2, Versa 4
Price
Charge 6 $159; Versa 4 $129; Sense 2 $249 (one-time purchase, no subscription required)
Pricing model
One-time hardware purchase + optional Fitbit Premium $9.99/month
Availability
Commercial — Google Store, Amazon, Best Buy, retailers

Availability and pricing

price
$110 (actual sale price) · as of 2025-07-09
lead time
Not disclosed
sales model
Not disclosed
availability
Shipping now
units in field
Not disclosed
pricing Model
Not disclosed

Safety record

Safety Status
Zero incidents on record

1 recall on record (1 serious). Most recent: Mar 2022.

Risk Metrics
Incidents: 0
Recalls: 1
Latest: Mar 2022
serious: 1

Supply chain

1 entry
  • QualcommCOMPUTE / SEMICONDUCTOR
    Qualcomm Qualcomm WSM6325 Health Wearable Platform -- dedicated biometric SoC in Fitbit Charge 6; low-power health sensor hub with integrated ECG, SpO2, and EDA processing

    Qualcomm Qualcomm WSM6325 Health Wearable Platform -- dedicated biometric SoC in Fitbit Charge 6; low-power health sensor hub with integrated ECG, SpO2, and EDA processing

FAQ

15 entries
What is Fitbit (Charge / Sense / Versa)?

Fitbit, founded in 2007 by James Park and Eric Friedman and acquired by Google in a roughly $2.1 billion deal that closed in January 2021, is now a Google product line rather than an independent company, and its devices are biometric-primary fitness bands and watches with atrial-fibrillation AI augmentation. Its current and last-generation devices include the Charge 6 from 2023, the Sense 2, and the Versa 4, carrying optical heart-rate sensing, ECG electrodes on the Sense line, a continuous electrodermal stress sensor on the Sense 2, blood oxygen, and skin temperature, plus Sleep Score, Sleep Profile, a Daily Readiness Score, and stress management. Its FDA clearances are the ECG app, cleared in September 2020 for on-demand assessment of atrial fibrillation versus sinus rhythm, and passive PPG-based Irregular Heart Rhythm Notifications, cleared on April 11, 2022 across a broad device range. Its blood oxygen, electrodermal stress, Sleep Score, and Daily Readiness features are wellness-grade and not FDA-cleared for any diagnostic claim. On current state, while standalone Fitbit-branded smartwatch hardware has been deprioritized with no Sense 3 and the smartwatch strategy consolidated onto the Pixel Watch, Google confirmed in October 2025 that new Fitbit hardware, expected to be trackers, is coming in 2026 along with a Fitbit Coach AI feature, so the line is deprioritized rather than dead. Its clinical-validation posture is the strongest in the cohort specifically on atrial fibrillation, anchored by the large prospective Fitbit Heart Study, while the 2026 Fitbit hardware specifications and the Fitbit Coach AI capabilities are unannounced and not verified.

How much does Fitbit (Charge / Sense / Versa) cost?

Fitbit (Charge / Sense / Versa) is listed at $110 on the DEPLOY registry. This is an actual sale price on record.

Is Fitbit (Charge / Sense / Versa) actually deployed in the real world?

Yes. Fitbit (Charge / Sense / Versa) is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.

Is Fitbit (Charge / Sense / Versa) autonomous or teleoperated?

Partly. DEPLOY verifies Fitbit (Charge / Sense / Versa) operating autonomously for Tracks sleep and Tracks fitness and activity. Other capabilities (Tracks heart health) are only demonstrated under teleoperation or remain vendor claims, not independently verified as autonomous.

What are the specs of Fitbit (Charge / Sense / Versa)?

Fitbit (Charge / Sense / Versa)'s recorded specifications on the DEPLOY registry: Battery: 7 days; Weight: 0.005 kg. See the Specs section for the full sourced set.

Who makes Fitbit (Charge / Sense / Versa)?

Fitbit (Charge / Sense / Versa) is made by Fitbit, based in San Francisco, California, USA, founded in 2007.

Where is Fitbit (Charge / Sense / Versa) deployed?

1 verified deployment of Fitbit (Charge / Sense / Versa) is on the DEPLOY registry, including at Global.

Can you buy Fitbit (Charge / Sense / Versa)?

Fitbit (Charge / Sense / Versa) is available for purchase - a real sale price is on record (see the pricing section for the figure and its source).

Is Fitbit (Charge / Sense / Versa) FDA cleared?

Fitbit (Charge / Sense / Versa) has 4 regulatory records on the DEPLOY registry: FDA 510(k) clearance (K212372), cleared; FDA 510(k) clearance (K212372), cleared; FDA 510(k) clearance (K200948), cleared and 1 more. See the Regulatory filings section for each agency source.

What are alternatives to Fitbit (Charge / Sense / Versa)?

On the DEPLOY registry, comparable biometric robots to Fitbit (Charge / Sense / Versa) include Blackrock Neuroport Array, BrainQ Non-Invasive BCI, Neko Body Scan, RNS System.

How does Fitbit (Charge / Sense / Versa) compare to Blackrock Neuroport Array?

Fitbit (Charge / Sense / Versa) and Blackrock Neuroport Array (Blackrock Neurotech · 5 deployments) are both biometric robots on the DEPLOY registry. Fitbit (Charge / Sense / Versa) has 1 verified deployment on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.

Is Fitbit (Charge / Sense / Versa) a top biometric?

On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Fitbit (Charge / Sense / Versa) ranks in roughly the top 59% of biometric models tracked by the registry.

What is Fitbit (Charge / Sense / Versa)'s maturity stage?

Fitbit (Charge / Sense / Versa) is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.

Is Fitbit (Charge / Sense / Versa) safe?

Fitbit (Charge / Sense / Versa) has 1 active incident on record in the DEPLOY registry. 1 recall on record (1 serious). Most recent: Mar 2022. Retracted incidents are excluded from this count.

What does a Fitbit tracker do?

Fitbit trackers (now part of Google) track fitness metrics including steps, heart rate, sleep, and activity. Fitbit is becoming Google Health, with Google Pixel Watch incorporating Fitbit features. Fitbit has FDA-cleared ECG under 510(k) K200948 and AFib detection under K212372.

Deployments

1 entry

Sectors & applications

1 entry