Loading…
LEEL Tech, a China-based medical device manufacturer, was cited for offering CLYN, LEEL, and SOLID CPAP devices for sale in the United States without required FDA marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. The devices were found to be adulterated because the company lacked either an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE), and were also misbranded for failing to submit a required premarket notification (510(k)) before commercial distribution. The FDA identified these violations through review of the company's website labeling and determined the products required regulatory clearance prior to U.S. market entry.