MEDICAL DEVICE AUTHORIZATION NOTICE: Federal (USA) law restricts this device to sale by or on the order of a practitioner licensed to use or order the use of this device. Purchase of this medical device requires that the user have supervision from a licensed medical practitioner. Devices requiring such supervision may be labeled "Caution" or "RX only". Ensuring this supervision is the purchaser's responsibility and the purchaser must acknowledge and accept the terms of this notice prior to sale. Authorization from a medical profession may be requested prior to fulfillment of this item.