Sale Of Over-The-Counter And Off-The-Shelf Devices

(1) “Over-the-counter device” means a prefabricated, mass-produced device that is prepackaged and requires no professional advice or judgment in either size selection or use, including fabric or elastic supports, corsets, generic arch supports and elastic hoses. (2) “Off-the-shelf device” means a prefabricated prosthesis or orthosis sized or modified for use by the patient in accordance with a prescription from a health care practitioner authorized by law to write such prescriptions and which does not require substantial clinical judgment and substantive alteration for appropriate use. (3) The sale of over-the-counter and off-the-shelf devices by non-licensed persons is not prohibited by these rules. (4) No person shall dispense or sell an over-the-counter device or an off-the-shelf device based upon an image of the customer’s limb captured by the person through a mold, cast, scanning device, digital appliance, or pressure sensitive device, unless the customer has first presented to that person a written prescription for that device from a health care practitioner authorized by law to write such a prescription.