BEUDAMED
    FDA Registration Active 🇺🇸 United States

    WHOOP ECG (electrocardiogram) Feature

    Reg #: 3031627845 · FEI: 3031627845 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Whoop, Inc.
    Registration Number
    3031627845
    FEI Number
    3031627845
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    One Kenmore Sq
    City
    Boston
    State
    MA
    ZIP
    02215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243236

    Owner / Operator

    Firm Name
    Whoop, Inc.
    Operator Number
    10093216
    Address
    One Kenmore Sq
    City
    Boston
    State
    MA
    Postal Code
    02215
    Country
    US
    Correspondent
    Niharika Trivedi

    Products

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

    Proprietary Names

    WHOOP ECG (electrocardiogram) Feature

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device