WHOOP ECG Feature

Primary DI
00860012964819
Brand
WHOOP ECG Feature
Company
Whoop, Inc.
Model
1.x
Published
2025-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QDAElectrocardiograph Software For Over-The-Counter Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDAElectrocardiograph Software For Over-The-Counter UseCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243236000WHOOP ECG (electrocardiogram) Feature (1.0)Whoop., Inc.2025-04-04QDA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012964819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012964819008600129648198600129648190860012964819

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, home-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079151198
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810028737815Google ECG AppFitbit LLCQDA2026-05-20
08806094948233Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDA2025-06-10
08806094948240Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDA2025-06-10
08806094940756Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDA2023-10-23
08806094940763Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDA2023-10-23
00860009117709Garmin ECG AppGarmin International, Inc.QDA2023-01-24
00860009117716Garmin ECG AppGarmin International, Inc.QDA2023-01-24
B210AC0210KardiaMobile CardAlivecor, Inc.QDA2022-07-13
08806092938823ECG Monitor AppSamsung Electronics Co., Ltd.QDA2021-08-25
00190199649286ECG 2.0 AppAPPLE INC.QDA2020-12-15
00190199649293ECG 2.0 AppAPPLE INC.QDA2020-12-15
00810038851983Fitbit ECG AppFitbit LLCQDA2020-10-07
08806090792021ECG Monitor AppSamsung Electronics Co., Ltd.QDA2020-09-24
08806090792045ECG Monitor AppSamsung Electronics Co., Ltd.QDA2020-09-24
B210AC0190KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L+Alivecor, Inc.QDA2020-05-01
00612479249455McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249486McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
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00612479249523McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249554McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249585McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249615McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22
00612479249677McKessonMCKESSON MEDICAL-SURGICAL INC.QDA2019-10-22