BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WHOOP ECG (electrocardiogram) Feature (1.0)

    K Number: K243236 · Decision Apr 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    176

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    WHOOP ECG (electrocardiogram) Feature (1.0)
    K Number
    K243236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2345
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Whoop., Inc.
    Date Received
    October 10, 2024
    Decision Date
    April 4, 2025
    Product Code
    QDA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QDA Electrocardiograph Software For Over-The-Counter Use

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QDA), ordered by most recent decision date.

    Withings ECG App

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Samsung ECG App v 1.3 (ECG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Garmin ECG App

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ECG App

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fitbit ECG App

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all