Active Medical Device
Active Medical Device : (a) Means a medical device that is intended by the manufacturer: (i) to depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity); and (ii) to act by converting that energy; but (b) does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between a medical device to which paragraph (a) applies and a human being without any significant change in the energy, substance, or other element being transmitted
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