Xtreme Personal Care Inc.

Xtreme Personal Care Inc. specializes in nasal lavage systems, which are devices designed for nasal hygiene and sinus irrigation. These systems help users flush out mucus and allergens from their nasal passages, typically for at-home use. The primary example is the XTREME device, which falls under this category.

Xtreme Personal Care Inc. is based in the United States. This location means its devices are subject to U.S. regulatory requirements, including classification under the FDA’s medical device regulations. The company’s nasal lavage systems are designed and manufactured in compliance with these standards.

Xtreme Personal Care Inc.’s nasal lavage systems are classified as Class I medical devices under FDA regulations. This classification is typically assigned to devices posing the lowest risk to patients, such as those with simple design and minimal risk of harm when used as intended. Class I devices often require less stringent premarket review but must still meet general controls.

Yes, Xtreme Personal Care Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to medical devices to improve tracking, transparency, and traceability in the healthcare system. Listing in this database helps ensure regulatory compliance and facilitates device identification for users and authorities.