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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, nerve, electrial, percutaneous (pens), for pain relief
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,
Product CodeNHI
Regulation Number 882.5890
Device Class 2