Medical Device Approvals for Fitbit Products

By Rhizome Team

Fitbit, a prominent name in wearable fitness technology, has evolved beyond consumer wellness devices to enter the regulated medical device market. Understanding which Fitbit products have received FDA clearance or approval provides insight into the company's strategic expansion into digital health and clinical applications.

Medical device approvals for wearable technology companies like Fitbit represent a significant regulatory milestone, requiring rigorous validation of device performance, safety, and clinical utility. These approvals enable healthcare providers to use these devices for diagnostic or therapeutic purposes beyond general wellness monitoring.

This analysis examines Fitbit's FDA-regulated medical device portfolio, detailing the specific products that have received regulatory clearance, their intended uses, and the regulatory pathways used to bring these devices to market.

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what medical device approvals does fitbit have?

Answer

Summary of Fitbit medical device approvals found in the provided documents (as of 2026-01-01)

Based on the FDA submission records included in the provided dataset, Fitbit has four identifiable FDA medical device clearances/authorizations (all 510(k) clearances in the excerpts provided), plus one Fitbit product with both a De Novo classification request and a subsequent 510(k) clearance. These approvals are primarily software-only, over-the-counter (OTC) features related to cardiac rhythm assessment and temperature measurement, plus one connected scale.

Fitbit devices cleared/authorized by FDA in the provided records

Fitbit ECG App — 510(k) clearance

  • Submission type / number: 510(k) K200948 216217218
  • FDA decision (clearance) date: September 11, 2020 217
  • Classification (as stated):
  • Intended use / key limitations (highlights):
    • Creates/records/displays a single-channel ECG similar to Lead I using Fitbit wrist-worn devices 216218219.
    • Determines presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform 216218219.
    • OTC use; ECG output is informational and users are not intended to take clinical action without consulting a qualified healthcare professional 220218219.
    • Not recommended for users with other known arrhythmias; not intended for people under 22 220218219.

Fitbit Irregular Rhythm Notifications — 510(k) clearance

  • Submission type / number: 510(k) K212372 676872
  • FDA decision (clearance) date: April 8, 2022 67
  • Classification (as stated):
  • Intended use / key limitations (highlights):
    • Software-only app used with compatible wrist-worn products to analyze PPG pulse-rate data and identify irregular rhythms suggestive of AFib, then notify the user 726870.
    • OTC feature; not intended to notify on every episode; lack of notification does not mean no disease 6870.
    • Data captured only when the user is still (not continuous monitoring) and notifications are limited (e.g., at most once per 24 hours) 7072.
    • Not intended for people under 22, and not intended for individuals previously diagnosed with AFib 6872.

Loss of Pulse Detection — 510(k) submission (decision date not shown in provided excerpts)

  • Submission type / number: 510(k) K242967 127130129
  • FDA decision/clearance date: Not explicitly present in the provided pages; the excerpts show “Date Prepared: Feb 19, 2025” and indicate decision year 2025 in metadata, but no definitive clearance date is visible in the supplied text 127129.
  • Classification (as stated):
    • Product code: SDY 129127
    • Regulation: 21 CFR 870.2790 127
    • Class: Class II 127
  • Intended use / key limitations (highlights):
    • Software-only app analyzing PPG data to identify loss of pulse events and provide audio/visual/haptic alerts; if unresponsive, it may prompt a call to emergency services via connected hardware 129127.
    • OTC; not diagnostic and not a replacement for traditional diagnosis/treatment/monitoring 130127129.
    • Opportunistic detection only; data captured when user is still and when signal quality requirements are met 129130132.
    • Not intended for people under 22 and not intended for certain higher-risk populations (e.g., previously diagnosed high risk for sudden cardiac death; also notes not intended for individuals previously diagnosed with AFib) 129127130132.

ARIA WiFi Smart Scale — 510(k) clearance

  • Submission type / number: 510(k) K133872 3415
  • FDA decision (clearance) date: June 2, 2014 141
  • Classification (as stated):
    • Product code: MNW 139141
    • Regulation: 21 CFR 870.2770 (Impedance plethysmograph) 139141
    • Class: Class II 139141
  • Intended use / key limitations (highlights):
    • Measures body weight and uses bioelectrical impedance analysis (BIA) to estimate body fat percentage in generally healthy individuals 10 years or older 139143140.
    • Intended for home use only and indicated as OTC/non-prescription in the submission materials 139143140.

Fitbit Body Temperature Software (BTS) — De Novo + subsequent 510(k) clearance (Fitbit LLC)

This is the only Fitbit item in the provided records that explicitly includes a De Novo classification request and a later 510(k) clearance.

Body Temperature Software (BTS) — De Novo classification request

  • Submission type / number: De Novo DEN230050 21
  • Receipt date shown: July 17, 2023 170
  • Classification (as stated):
  • Indications / key limitations (highlights):
    • OTC software-only app using a general purpose infrared sensor for intermittent determination of human body temperature on people of all ages 173170.
    • Not intended for measuring temperature of a premature baby (≤37 weeks gestational age at birth) (not tested) 170.
    • Not intended to diagnose/monitor serious conditions; users should not take clinical action without consulting a healthcare professional 170.

Body Temperature Software (BTS) — subsequent 510(k) clearance

  • Submission type / number: 510(k) K243778 5161
  • FDA decision (clearance) date: February 13, 2025 168169
  • Intended use statement (restated in 510(k) materials):
    • Same OTC intermittent body temperature determination language is reiterated in the 510(k) summary 169.

What was not counted (scope notes)

The dataset includes many FDA submissions for non-Fitbit companies (e.g., Apple, Samsung, Garmin, Withings, AliveCor, etc.). Those are explicitly described in the context as not Fitbit-related and therefore do not represent Fitbit approvals. For example, Samsung ECG app submissions are present but are labeled as Samsung, not Fitbit, and should be excluded when answering “what approvals does Fitbit have?” 131617.

Practical implications of these approvals

Across the Fitbit entries above, the FDA-cleared functions are largely positioned as OTC, informational/screening-support tools rather than definitive diagnostic systems:

  • The cardiac features (ECG, irregular rhythm notifications, loss-of-pulse detection) emphasize user notification and informational output, with repeated limitations such as not replacing traditional diagnosis/treatment, stillness-dependent data capture, and adult-only (22+) restrictions 220218219687072129130132.
  • The scale clearance supports consumer home measurement of weight and estimated body fat percentage using BIA, with a stated population of generally healthy individuals 10+ 139143140.
  • The temperature software is cleared for intermittent temperature determination (not continuous monitoring) and includes explicit cautions about not using it as a substitute for professional medical consultation and not for certain neonatal populations 170173.

If you want, I can also extract these into a concise list you can copy/paste (device → submission number → clearance date), but the details above reflect what is explicitly supported by the provided FDA excerpts and citations.