HARMONIZE INC.

Harmonize Inc. specializes in two primary device categories: bioelectrical body composition analysers and patient monitoring system modules for noninvasive blood pressure measurement. Their bioelectrical analysers assess body fat, muscle mass, and hydration levels using electrical impedance analysis, while the blood pressure modules integrate into larger patient monitoring systems for real-time physiological tracking. These devices are designed for both clinical and home-use environments to provide detailed patient assessments.

Harmonize Inc. is based in the United States, which means its devices must comply with FDA regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring transparency and traceability. Since the U.S. has strict medical device oversight, the manufacturer aligns its operations with domestic standards, including classification under FDA’s risk-based categories (Class I and Class II).

Harmonize Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling tracking, traceability, and compliance verification within the U.S. regulatory framework. This listing helps ensure transparency and adherence to FDA requirements for medical instrumentation.

Harmonize Inc.’s devices fall under FDA’s Class I and Class II classifications, which determine the level of regulatory oversight based on risk. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification helps the FDA tailor regulatory requirements to the specific risks associated with each device type.

Harmonize Inc.’s bioelectrical body composition analysers measure body fat, muscle mass, and hydration levels by analyzing electrical impedance through the body. These devices are used in clinical and home settings to provide objective, real-time data for assessing patient health, nutritional status, and metabolic function. The technology helps healthcare providers and individuals monitor physiological changes over time.