1) transcranial Alternating Current Stimulation (tACS)
including Cranial Electrotherapy Stimulation (CES)
Is a method of brain stimulation which has been used since the 1950s, and was FDA approved for Depression, Anxiety, Pain & Insomnia in the Early 1970s.*
*Class III for the indication of “insomnia, depression, and anxiety” through a “pre-amendment” regulatory pathway (510[k]), which required only demonstration of substantial equivalence to legally marketed devices predating FDA regulation)Class III for the indication of “insomnia, depression, and anxiety” through a “pre-amendment” regulatory pathway (510[k]), which required only demonstration of substantial equivalence to legally marketed devices predating FDA regulation)