FDA Device Entity Profile: Whoop, Inc.

Known Identifiers & Locations

FEI Numbers 3031627845

Owner Operator Numbers 10093216

Locations Covered Boston, MA, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3031627845	Whoop, Inc.	Boston, MA, US	Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K243236	WHOOP ECG (electrocardiogram) Feature (1.0)	2025-04-04	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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