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510(k) K200948

Fitbit ECG App by Fitbit, Inc. — Product Code QDA

K200948 is an FDA 510(k) premarket notification submitted by Fitbit, Inc. for the device "Fitbit ECG App". The FDA issued a decision of Substantially Equivalent on September 11, 2020. The device falls under product code QDA (Electrocardiograph Software For Over-The-Counter Use), a Class II device regulated under 21 CFR 870.2345. Fitbit, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2020
Date Received
April 8, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph Software For Over-The-Counter Use
Device Class
Class II
Regulation Number
870.2345
Review Panel
CV
Submission Type

An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.

Other clearances by Fitbit, Inc.

  • K242967 — Loss of Pulse Detection (February 25, 2025)
  • K243778 — Body Temperature Software (BTS) (February 13, 2025)
  • DEN230050 — Body Temperature Software (BTS) (December 15, 2023)
  • K212372 — Fitbit Irregular Rhythm Notifications (April 8, 2022)
  • K133872 — ARIA WIFI SMART SCALE (June 2, 2014)

Other clearances for product code QDA

  • K240795 — Withings ECG App (June 15, 2025)
  • K243236 — WHOOP ECG (electrocardiogram) Feature (1.0) (April 4, 2025)
  • K240909 — Samsung ECG App v 1.3 (ECG) (August 2, 2024)
  • K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (May 2, 2023)
  • K221774 — Garmin ECG App (January 12, 2023)
  • K201525 — ECG App (October 8, 2020)
  • K201168 — ECG Monitor App (August 4, 2020)
  • DEN180044 — ECG App (September 11, 2018)

FDA data resources