Korea New Tech Co., Ltd.

Korea New Tech Co., Ltd. specializes in lumbar spine orthoses, which are external devices designed to provide support and stabilization for the lower back. These devices are intended for over-the-counter use to help manage discomfort or restrict movement in the lumbar region, typically for conditions like back strain or mild instability.

Korea New Tech Co., Ltd. is based in the United States. This location influences its regulatory compliance, as the company must adhere to U.S. medical device regulations, including those governing classification, labeling, and reporting requirements for its products.

The devices produced by Korea New Tech Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for regulatory and clinical purposes.

The lumbar spine orthoses manufactured by Korea New Tech Co., Ltd. are classified as Class I medical devices under U.S. regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, allowing for streamlined oversight while still ensuring compliance with safety and performance standards.