Cleared Traditional

WHOOP ECG (electrocardiogram) Feature (1.0)

K243236 · Whoop., Inc. · Cardiovascular
Apr 2025
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K243236 is an FDA 510(k) clearance for the WHOOP ECG (electrocardiogram) Feature (1.0), a Electrocardiograph Software For Over-the-counter Use (Class II — Special Controls, product code QDA), submitted by Whoop., Inc. (Boston, US). The FDA issued a Cleared decision on April 4, 2025, 176 days after receiving the submission on October 10, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2345.

Submission Details

510(k) Number K243236 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2024
Decision Date April 04, 2025
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QDA — Electrocardiograph Software For Over-the-counter Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2345
Definition 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.