The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
The FDA has established classifications for close to 2,000 different generic types of devices and groups them into 16 sub-sets of medical specialties they call panels. Within each panel there could be hundreds of products, each of which gets a code. (Think Tax Code for medical stuff!) Each of these generic types of devices is assigned to one of three regulatory classes, often referred to as “Classifications.” What class a product is placed in depends upon a number of factors. Intended use, if the device is surgically invasive or not, the level of control necessary to assure the safety and effectiveness of the device, and the risk the device poses to the user are key factors. The following guidelines for classifications was extracted from the website of Innovatum, a regulatory compliance company.
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Class I Devices – Class I devices are considered to be at the lowest level of risk of all medical devices and are therefore required to comply with the lowest level of regulatory control. Examples of Class I devices include: elastic bandages, dental floss and enemas.
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Class II Devices – Class II devices are simple devices, though they are more complicated than Class I devices. They require more stringent regulatory controls to provide assurance of their effectiveness and safety. Examples of Class II devices include: condoms, pregnancy testing kits and powered wheelchairs.
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Class III Devices – Class III devices are generally considered to be the most complex devices. They are also considered to be at the highest risk and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety. Examples of Class III devices include: implantable pacemakers and breast implants.
The BEMER Pro Set GO (B.Box, B.Pad, B.Spot) is cleared and recognized by the FDA as a Class II device.We are in category “890”, which refers to Physical Medicine and our product code is NGX (not an acronym), and our regulatory name is a “Powered Muscle Stimulator.”
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