Fitbit (Charge / Sense / Versa)
[commercial]biometric · food-service · 1 deployments in catalog
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
FitbitForm 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
- 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
1 recall on record (1 serious). Most recent: Mar 2022.
Supply chain
- QualcommCOMPUTE / SEMICONDUCTORQualcomm 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
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.