WHOOP ECG Feature

Basic Information

• Brand Name: WHOOP ECG Feature
• Primary DI: 00860012964819
• Version / Model: 1.x
• Company Name: Whoop, Inc.
• Labeler DUNS: 079151198
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-10
• Public Version: 1
• Public Version Date: 2025-06-18
• Public Version Status: New
• Public Device Record Key: d99789dc-f37e-466b-8dc9-9467c2ce6c6a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QDA	Electrocardiograph Software For Over-The-Counter Use	Cardiovascular	870.2345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62641	Electrocardiograph, home-use	A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012964819	GS1

Premarket Submissions

Submission Number	Supplement Number
K243236	000