FDA 510(k) Premarket Notification K243236: WHOOP ECG (electrocardiogram) Feature (1.0)

Submission Details & Decision

Normalized public record details for 510(k) notification K243236.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K243236

Applicant / Sponsor

Whoop., Inc.

Device Name

WHOOP ECG (electrocardiogram) Feature (1.0)

Product Code

QDA

Decision Date

2025-04-04

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-10-10

Related Establishments / Registrations

GARMIN INTERNATIONAL, INC. Registration: 1000500214 View Registration
Omron Healthcare, Inc. Registration: 1450057 View Registration
RR DONNELLEY-SUPPLY CHAIN SOLUTIONS Registration: 3006371704 View Registration
Cardiabase Registration: 3007184699 View Registration
Withings Registration: 3008820594 View Registration
FITBIT LLC Registration: 3009253624 View Registration
AliveCor Registration: 3009715978 View Registration
RYDER ELECTRONICS (SHENZHEN) LTD. Registration: 3011235999 View Registration
QUIPMENT INC. Registration: 3012302888 View Registration
ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V. Registration: 3012516456 View Registration
Hypertec HCM LLC Registration: 3013896610 View Registration
APPLE INC. Registration: 3014343954 View Registration
ICON LLC Registration: 3014522540 View Registration
TECAN CDMO SOLUTIONS PN SDN. BHD. Registration: 3015134086 View Registration
Samsung Electronics Co., Ltd. Mobile eXperience Business Registration: 3017616353 View Registration
Whoop, Inc. Registration: 3031627845 View Registration
OMRON HEALTHCARE CO., LTD. Registration: 8030245 View Registration
OMRON HEALTHCARE Co., Ltd. Matsusaka Factory Registration: 9611045 View Registration

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