DASTMALCHI LLC

Dastmalchi LLC specializes in bioelectrical body composition analysers, which measure metrics like body fat percentage, muscle mass, and hydration levels. These devices use electrical resistance analysis to provide insights into a user’s body composition. They are designed for consumer use in home settings, often paired with digital platforms for tracking and reporting results.

Dastmalchi LLC is based in the United States. Its devices are intended for use in the US market, where they must comply with applicable FDA regulations for bioelectrical impedance analysers. The company does not specify international markets or jurisdictions for its products.

Dastmalchi LLC’s bioelectrical analysers fall under FDA Class II regulatory classification. This classification is used for devices that pose moderate risk and require special controls to ensure safety and effectiveness. The classification is determined by the FDA based on factors like the device’s intended use and potential health impact.

Yes, Dastmalchi LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for medical devices authorised for use in the US. The company does not reference listings in other regulatory registries or jurisdictions.

Dastmalchi LLC’s devices are consumer-focused bioelectrical impedance analysers, primarily designed for home use. They measure body composition metrics like fat percentage and muscle mass through electrical resistance, often integrating with digital platforms for user-friendly tracking. Their FDA Class II classification indicates they are subject to stricter regulatory oversight compared to lower-risk devices, ensuring compliance with safety and performance standards.