Chinese devicemakers continue to land in the FDA’s crosshairs, with the agency tacking on two more companies to an import alert list.
Hongkong Canwin Li Health Products and Shenzhen Beierkang Technology have found themselves as the newest members of the “Detention Without Physical Examination” import alert list for devices without approved PMAs or IDEs, or those that are not substantially equivalent without a 510(k).
Shenzhen-based Hongkong Canwin Li Health Products manufactures external penile rigidity devices, and was cited on the alert for its “PowerUp Penis Pump.”
Shenzhen Beierkang Technology was hit for its “Multifunction Infrared Thermometer.” The FDA says it doesn’t have information about the product materials and cannot determine whether it is a device subject to a previously cleared 510(k). — Michael Cipriano