Whoop, Inc.

FDA Device Registration & Listing · Boston, MA, US · Registration 3031627845

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031627845
FEI Number
3031627845
Entity Name
Whoop, Inc.
City/State/Country
Boston, MA, US
Establishment Address
One Kenmore Sq, Boston, MA 02215, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Whoop, Inc. (Owner Number: 10093216)
Owner / Operator Contact Address
One Kenmore Sq, Boston, MA 02215, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243236
PMA Number
N/A

All Registered Proprietary Names

WHOOP ECG (electrocardiogram) Feature

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QDA Electrocardiograph Software For Over-The-Counter Use Cardiovascular Class 2 870.2345 2025-04-15

Official Correspondent

Niharika Trivedi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Whoop, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243236 Whoop., Inc. WHOOP ECG (electrocardiogram) Feature (1.0) 2025-04-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031627845. Last updated year: 2026. Please use registration number 3031627845 when referencing this establishment in official correspondence.
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