PARADIGM HEALTH & WELLNESS, INC.

Paradigm Health & Wellness, Inc. specializes in bioelectrical body composition analysers, such as the MyCloudFitness and Prevention devices. These tools use bioelectrical impedance analysis to assess body metrics like fat mass, muscle mass, and hydration levels, helping users monitor overall health and wellness.

The company is headquartered in the United States. This location ensures compliance with U.S. regulatory standards, including those governing medical devices.

The devices produced by Paradigm Health & Wellness, Inc., such as bioelectrical body composition analysers, fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency in the regulatory and healthcare supply chains, helping track devices throughout their lifecycle.