Globally Recognized and
Certified as a New Medical Technology
Global
  • - CE approved in 2008 (Europe)
  • - FDA approved in 2009 (USA)
  • -Assigned by the American Medical Association the code *CPT-III in 2012
  • * CPT-III: [0278T] Transcutaneous electrical modulation pain reprocessing (e.g., Scrambler Therapy®), each treatment session (includes placement of electrodes) (USA)
Korea
  • - KFDA approved in 2011 (Korea); Classification amended to ‘Transcutaneous electrical modulation system scrambling (A16010.03)’
  • - Approved by National Evidence-based Healthcare Collaboration Agency as a new medical technology (Non-invasive, artificial neuronal, no pain signal therapy)
  • - Approved by Korean Ministry of Health and Welfare as a new medical technology (2013)
  • - Classified as a non-covered healthcare service by the Korean Ministry of Health and Welfare (2014)- Scrambler Therapy®, Code: MZ012, ‘Non-invasive no pain signal therapy’