In the July 3, 2014, Federal Register, FDA issued a final order classifying the transcutaneous electrical nerve stimulator to treat headache into Class II with special controls, effective August 4, 2014. In the July 8, 2014, Federal Register, FDA issued a final order classifying the transcranial magnetic stimulator for headache into Class II with special controls, effective August 7, 2014. The special controls applicable to the device will be part of the codified language for the transcranial magnetic stimulator for headache classification.
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