K243236 is an FDA 510(k) clearance for the WHOOP ECG (electrocardiogram) Feature (1.0). Classified as Electrocardiograph Software For Over-the-counter Use (product code QDA), Class II - Special Controls.
Submitted by Whoop., Inc. (Boston, US). The FDA issued a Cleared decision on April 4, 2025 after a review of 176 days - an extended review cycle.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2345 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Whoop., Inc. devices
NCT06622265
Completed
Observational
Industry-sponsored
WHOOP ECG Software Performance Assessment Study
Multi-phase, Prospective, Multicenter, Non-interventional, Pre-market, Non-randomized, Open-label Study to Evaluate the Clinical Performance of the WHOOP ECG Feature
| Condition studied |
Atrial Fibrillation (AF) |
| Eligibility |
All sexes
· 22 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Gerald Early, M.D. |
| Sponsor |
Whoop Inc.
(industry)
|
Started 2024-05-15
→
Primary completion 2024-07-03
Primary outcome
Specificity of the WHOOP ECG Feature for detection of sinus rhythm
Study completed - no results published.
This trial concluded in 2024 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov