OKAMOTO USA, INC.

OKamoto USA, Inc. primarily manufactures two main types of devices: single-use latex male condoms in various sizes and designs (such as standard, extra-large, and color-assorted varieties) and reusable hot/cold therapy packs for localized temperature treatment. These products are designed for different consumer needs, with condoms serving as a barrier contraceptive and the therapy packs providing thermal relief.

OKamoto USA, Inc. is based in the United States, which means its devices are subject to U.S. regulatory requirements, including those set by the FDA. Since the company’s products fall under FDA classifications—condoms as Class I and thermal therapy packs as Class II—they must comply with U.S. medical device regulations, including mandatory listing via the FDA’s 510(k) pathway and Unique Device Identifier (UDI) system.

OKamoto USA, Inc.’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices under U.S. regulatory oversight, confirming compliance with FDA requirements for both condoms (Class I) and thermal therapy packs (Class II).

OKamoto USA, Inc.’s devices are classified based on their risk levels and intended use. Basic male condoms fall under Class I, which typically includes low-risk devices requiring general controls for safety and effectiveness. In contrast, the company’s hot/cold therapy packs are classified as Class II, indicating a moderate risk that necessitates special controls beyond general regulations to ensure their safe and effective performance.

The FDA mandates a Unique Device Identifier (UDI) for all medical devices to improve tracking, reduce medical errors, and enhance post-market surveillance. Since OKamoto USA, Inc.’s devices—including both condoms and thermal therapy packs—are listed under the FDA’s UDI system, each product is assigned a unique code that distinguishes it from others, ensuring accurate identification in regulatory databases and clinical settings.