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510(k) K240795

Withings ECG App by Withings — Product Code QDA

K240795 is an FDA 510(k) premarket notification submitted by Withings for the device "Withings ECG App". The FDA issued a decision of Substantially Equivalent on June 15, 2025. The device falls under product code QDA (Electrocardiograph Software For Over-The-Counter Use), a Class II device regulated under 21 CFR 870.2345. Withings has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2025
Date Received
March 22, 2024
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 Withings

  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K231667 — Withings Sleep Rx (September 6, 2024)
  • K230812 — Withings Scan Monitor 2.0 (August 23, 2023)
  • K201456 — Scan Monitor (October 5, 2021)
  • K160544 — Withings Thermo (Model SCT01) (June 17, 2016)
  • K133125 — WITHINGS BLOOD PRESURE MONITOR (March 24, 2014)
  • K110872 — WITHINGS BLOOD PRESSURE MONITOR (May 20, 2011)

Other clearances for product code QDA

  • 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)
  • K200948 — Fitbit ECG App (September 11, 2020)
  • K201168 — ECG Monitor App (August 4, 2020)
  • DEN180044 — ECG App (September 11, 2018)

FDA data resources