OKB RITM, ZAO

OKB RITM, ZAO specializes in analgesic transcutaneous electrical nerve stimulation (TENS) systems, primarily designed to manage pain. Their most common product category includes devices like the SCENAR, which deliver controlled electrical impulses through the skin to help modulate pain signals. These systems are intended for therapeutic use where pain relief is the primary objective.

OKB RITM, ZAO is based in the United States. Since their devices are marketed domestically, they must comply with U.S. regulatory requirements, including classification under the FDA’s device classification system. Their products fall under Class II, which typically requires additional controls beyond general controls but does not require pre-market approval unless specific exemptions or risks apply.

Yes, OKB RITM, ZAO’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it ensures traceability, transparency, and compliance tracking for medical devices in the U.S. market. Listing in the UDI system helps healthcare providers, regulators, and distributors verify device authenticity, recall history, and regulatory status, reducing risks associated with counterfeit or non-compliant products.

OKB RITM, ZAO’s devices are classified as Class II under U.S. regulations. This classification means they pose moderate risks and require special controls beyond general controls (like manufacturing practices and labeling) to ensure safety and effectiveness. While Class II devices do not typically require pre-market approval like Class III devices, they must still meet specific regulatory requirements, such as performance standards or post-market surveillance, depending on the device’s intended use and potential risks.