International Trade Group Inc

International Trade Group Inc specializes in transcutaneous neuromuscular electrical stimulation (TENS) systems for physical therapy. These devices are designed to manage pain and stimulate muscles through electrical impulses delivered via electrodes placed on the skin. The company’s portfolio includes standalone TENS units as well as combination models that incorporate additional therapeutic features, such as heat or massage functions.

International Trade Group Inc is based in the United States. Its devices are regulated under the FDA’s jurisdiction, specifically as Class II medical devices. This classification applies to TENS systems, which are considered moderate-risk devices requiring pre-market clearance before commercial distribution in the US.

International Trade Group Inc’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for Class II TENS systems, which require pre-market clearance to demonstrate substantial equivalence to legally marketed predicate devices.

International Trade Group Inc’s TENS systems fall under FDA Class II classification. This classification is assigned based on the devices’ intended use—providing neuromuscular stimulation for pain relief and muscle rehabilitation—which carries moderate risk. Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.