LIVIN WELLNESS, LLC

Livin Wellness, LLC specializes in three primary categories of medical devices: bioelectrical body composition analysers, pulse oximeters, and infrared patient thermometers for skin. The bioelectrical analysers assess body composition by measuring electrical impedance to estimate fat, muscle mass, and hydration levels. Pulse oximeters monitor blood oxygen saturation and heart rate non-invasively, while the infrared thermometers provide quick temperature readings for clinical or home use. These devices are designed to support health monitoring and diagnostics in various settings.

Livin Wellness, LLC is based in the United States. This means its devices are developed and marketed in compliance with U.S. regulatory standards, including those set by the FDA. The company’s products are subject to FDA oversight, which includes classification, registration, and listing requirements to ensure safety, performance, and compliance with applicable regulations before they enter the market.

Livin Wellness, LLC’s devices are classified as FDA Class II. This classification indicates that while the devices pose moderate risk, they require general controls (like labeling, manufacturing practices, and registration) *and* special controls to ensure their safety and effectiveness. Special controls for Class II devices often include performance standards, post-market surveillance, or guidance documents tailored to the device’s specific risks. This classification helps regulators and users understand the level of scrutiny and oversight applied to these products.

Yes, Livin Wellness, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, improving tracking, traceability, and transparency in the supply chain. Listing in the UDI database ensures that healthcare providers, regulators, and other stakeholders can easily locate and verify the device’s details, such as its model, manufacturer, and regulatory status, which supports better inventory management and compliance efforts.