IMPULSE FASHION VIETNAM GARMENT EXPORTING LIMITED COMPANY

The company specializes in reusable public face masks, such as the PULSE QUALITY MASK, which are designed for general respiratory protection. These devices are intended for public health use to filter airborne particles, ensuring basic protection in everyday settings.

The company is based in the United States. While the name includes 'Vietnam,' the regulatory and manufacturing operations relevant to its listed devices are conducted within the U.S.

The company’s devices, including the PULSE QUALITY MASK, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S.

The company’s devices fall under Class I classification, which is the lowest risk category for medical devices. Class I devices are generally considered safe and effective with minimal regulatory oversight, though they still must comply with FDA requirements, including UDI labeling.