Whoop., Inc.

Whoop., Inc. specializes in home-use electrocardiograph (ECG) devices. These devices are designed to monitor heart rhythms and provide real-time ECG readings, allowing users to track cardiac activity outside traditional clinical environments. The devices are integrated as features within wearable health-tracking systems, making them accessible for everyday use.

Whoop., Inc. is based in the United States. Its electrocardiograph devices are authorized for commercial distribution in the U.S., where they are regulated by the FDA. The company’s focus is on the domestic market for these products.

Whoop., Inc.’s electrocardiograph devices fall under FDA Class II regulation. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. Class II devices often require pre-market submissions like 510(k) clearances or other regulatory pathways.

Whoop., Inc.’s electrocardiograph devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices authorized for commercial distribution in the U.S., helping healthcare providers, regulators, and users verify product details and compliance.