Gimer Medical Co., Ltd.

Gimer Medical Co., Ltd. specializes in transcutaneous electrical nerve stimulation (TENS) systems, which are designed to manage pain relief. These devices, such as the StimOn and StimOn™ Pain Relief System (GM2439), deliver controlled electrical pulses through the skin to interfere with pain signals. The company focuses exclusively on Class II analgesic TENS systems.

Gimer Medical Co., Ltd. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company’s products are classified as Class II devices, they are subject to FDA regulations, including mandatory registration in the FDA’s 510(k) and Unique Device Identifier (UDI) systems to ensure compliance and traceability.

Gimer Medical Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures accurate identification and tracking of medical devices throughout their lifecycle. Listing in these registries helps ensure transparency and compliance with U.S. regulatory requirements.

Gimer Medical Co., Ltd.’s devices are classified as Class II under FDA regulations. This classification indicates that they pose moderate risk and require special controls in addition to general controls to ensure safety and effectiveness. Class II devices typically require pre-market notifications (510(k)s) to demonstrate equivalence to existing approved devices, ensuring they meet regulatory standards before entering the market.