The Joeyband™ is registered with the FDA as a Class 1 Medical Device.
FDA Certification and Class 1 Medical Device Classification
The Joeyband™ is proudly registered with the U.S. Food and Drug Administration (FDA) as a Class 1 Medical Device, ensuring that it meets stringent standards for safety and efficacy. Our FDA Registration # is 3026932001.
Understanding the FDA
The FDA, or Food and Drug Administration, is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
What Does Class 1 Medical Device Mean?
Class 1 Medical Devices are considered to have the lowest risk associated with their use and are subject to the least regulatory control. Class 1 devices are subject to General Controls as outlined by the FDA, which include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; and good manufacturing practices.
The Class 1 designation of the Joeyband™ demonstrates our commitment to providing a product that is safe, reliable, and of the highest quality. This classification assures our customers that the Joeyband™ adheres to the essential requirements of health, safety, and environmental protection standards for products sold within the United States.