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<br>In addition to requesting opinions on the proposal typically, we especially sought opinions on the determinations that the possibility of health issues or injury posed by ESDs for SIB or AB is unreasonable and substantial, and that labeling or a modify in labeling can not correct or eliminate the unreasonable and sizeable risk of health issues or damage. This ban includes the two new products and products now in distribution and use on the other hand, this ban delivers transition time for those persons at present matter to ESDs for the discovered intended use to transition off ESDs underneath the supervision of a physician. The ban applies to devices already in commercial distribution and products previously bought to the final (conclude) consumer, as nicely as gadgets to be offered or commercially dispersed in the long run. Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Food and Drug Administration, HHS. 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As a outcome, the depth or agony of a individual set of shock parameters can differ from person to person and from Start Printed Page 13313shock to shock. However, SIB can be extra extreme and outcome in: (1) Bleeding (2) damaged, even protruding bones (3) blindness from eye-gouging or poking (4) other long lasting tissue damage or (5) injuries from swallowing perilous objects or substances<br>