The device was banned by the United States Food and Drug Administration in 1970 as it was deemed to be potentially unhealthy and dangerous to the users.   The case went to court, and the United States District Court for the Central District of California held that the Relax-A-Cizor was a "device" within the meaning of 21 . § 321 (h) because it was intended to affect the structure and functions of the body as a girth reducer and exerciser, and upheld the FDA's assertions that the device was potentially hazardous to health. 
Muscle Structure and Function:
There are three levels of muscle tissue organization: epimysium, endomysium, and perimysium. These three levels are a consequence of differing sizes and orientations of connective tissue fibers, particularly collagen (figure ). The outside surface of a muscle is covered by a relatively thick and very tough connective tissue, the epimysium, which separates it from surrounding muscles. Arteries and veins run through the endomysium. The collagen fibers of the epimysium are woven into particularly tight bundles that are wavy in appearance. These collagen bundles are connected to the perimysium. The perimysium divides the muscle into bundles typically containing about 100 to 150 muscle fibers, which form a fasciculus or fascicle. However, muscles that function in producing small or very fine movements have smaller fascicles containing relatively few fibers and a larger proportion of connective tissue (Gowitzke and Milner 1988). The muscle fibers take on a polygonal cross-sectional shape that allows a greater number of fibers to fit into a fascicle (McComas 1996). Typically the interstitial spaces between fibers are about 1 µm. The perimysium also forms connective tissue tunnels, the intramuscular septa, which run through the muscle belly and provide a pathway for larger arterioles, venules, and nerves. The perimysium contains many large collagen bundles that encircle the outer surface of the muscle fibers lying on the outside of a fascicle. Some of the collagen bundles encircle the fascicles in a cross pattern, adding stability to the structure of the fascicle. Underneath the thicker perimysial sheets of connective tissue is a much looser network of collagen fibers that run in various directions and connect with the endomysium. The endomysium, which is made up of collagen fibers 60 to 120 nm in diameter, surrounds each muscle fiber, again adding more stability. Capillaries run between individual muscle fibers and lie within and are stabilized by the endomysium. Many of the endomysial fibers connect with the perimysium and likely connect to the basement membrane, which lies on the outside of the muscle cell sarcolemma (McComas 1996).