VIBRATEX, INC.

Vibratex, Inc. specializes in hand-held electric massagers, primarily designed for personal use. These devices, such as the Magic Wand®, are intended to provide muscle relaxation and pain relief through vibration therapy. The company focuses on this single category of Class I medical devices.

Vibratex, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s medical device hierarchy. The U.S. regulatory framework applies to ensure compliance with safety and performance standards for these products.

Vibratex, Inc.’s devices, such as the Magic Wand®, are classified as Class I medical devices under U.S. regulations. This classification is the lowest risk tier, typically reserved for devices with minimal potential risk to users. It means these products undergo less stringent premarket review but still must comply with general controls, such as proper labeling and manufacturing practices, to ensure safety and effectiveness.

Yes, Vibratex, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency in the supply chain and aiding in post-market surveillance. Listing in this database is a requirement for Class I devices in the U.S. to facilitate regulatory oversight and market transparency.