Is the BodyMedia Armband a medical device?
This determination is dependent upon regulatory requirements in each country. In the United States, the product is FDA regulated and development follows industry standard practices for development and testing of medical devices (GMP). The product is a Class II medical device, exempt from the requirements for a pre-market notification 510(k). The product is registered with the FDA as 513(g) Number C030022, regulation 21CFR8901925, FDA Product Code IKK. In Canada the product is not considered a medical device.
