Although many people are familiar with medical devices, they don't know much about them. Many doctors also asked the customer service manager: what kind of medical devices are your devices? What are the consumables? The four classics integrated medium frequency therapeutic apparatus belongs to class II medical devices, while consumables belong to class I medical devices, and relevant filing and qualification will be delivered with the products.
Class I medical devices
The first type of risk is low, and the implementation of routine management can ensure its safety and effective medical devices. For example: surgical instruments (knife, scissors, forceps, tweezers, hooks), scraping plate, medical X-ray film, surgical clothes, surgical caps, inspection gloves, gauze bandages, drainage bags, etc.
Class II medical devices
The second category has moderate risk, which requires strict control and management to ensure its safety and effective medical devices. For example: medical suture needle, sphygmomanometer, thermometer, electrocardiograph, electroencephalograph, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection equipment, non absorbable suture, condom, etc. (the four meridians integrated medium frequency therapeutic apparatus belongs to class II)
Class III medical devices
The third kind of medical devices with high risks need to take special measures to strictly control and manage to ensure their safety and effectiveness. Such as: implantable pacemaker, corneal contact lens, intraocular lens, ultrasound tumor focusing knife, hemodialysis device, implantable equipment, vascular stent, comprehensive anesthesia machine, dental implant materials, medical absorbable suture, intravascular catheter, etc.