Original idea was sell as whole think but after taking a part I wasn't sure that I can put it back together so goes for parts. E and local regulatory agencies. The sale of this item may be subject to regulation by the U. Food and Drug Administration and state and local regulatory agencies.If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA's Center for Devices and Radiological Health. 4754 Franchise St N charleston 29418 8502763136.