The U.S. Food and Drug Administration (FDA) is responsible for classifying all devices based upon the level of control necessary to assure the safety and effectiveness of the device.
Class I devices are subject to the least regulatory control and usually present minimal potential for harm to the user. Examples of Class I devices include elastic bandages, examination gloves, non-absorbable gauze, manual wheelchairs, crutches, walkers, nonprescription sunglasses, incontinence garments, eye pads and enema kits.
Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness and are therefore also subject to special controls. Examples of Class II devices include powered wheelchairs, infusion pumps, sterile surgical drapes, blood glucose meters, nebulizers, x-ray systems, TENS units, oxygen concentrators, lasers and diagnostic ultrasound devices.
Class III devices are subject to the most stringent regulatory controls and are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Examples of Class III devices include implantable defibrillators, coronary stents, spinal cord stimulators, hip joint implants and cardiopulmonary bypass pumps.
