Atlantic Trading LLC

Atlantic Trading LLC produces hot/cold therapy packs (both single-use and reusable), perineal coolers, and surgical/medical respirators that are non-antimicrobial and single-use. These devices are designed for wound care, pain management, inflammation reduction, patient comfort after procedures, and short-term ventilation in clinical settings.

Atlantic Trading LLC is based in the United States. Since the company operates within the U.S., its devices must comply with applicable U.S. regulatory requirements, including classification under FDA’s regulatory framework. This ensures alignment with local standards for safety, performance, and post-market surveillance.

Atlantic Trading LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes.

Atlantic Trading LLC’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. Classification depends on factors like intended use, potential harm, and design complexity.