Worldwide regulatory
clearance and approval
Overseas
  • - Approved by CE (Europe) in 2008
  • - Approved by FDA (US) in 2009
  • - Obtained the Code CPT-III in 201 from the AMA – 0278T Transcutaneous electrical modulation pain reprocessing (e.g., Scrambler Therapy®), each treatment session (includes placement of electrodes)
Domestic
  • - Approved as a medical treatment device by KFDA in 2011 Reclassification to ‘transcutaneous electrical modulation system, scrambling (A16010.03)’
  • - Selected as ‘New Health Technology’ Evaluation by the NECA (National Evidence-based Healthcare Collaboration Agency): Non-invasive, artificial neuron non-pain method
  • - Approved as ‘New Health Technology’ assessed by the Korean Ministry of Health and Welfare on February 28, 2013
  • - Acquired the Non-insurance Coverage notification by the Korean Ministry of Health and Welfare on May 29, 2014: Code – non-invasive method for pain treatment_Scrambler Therapy®(MZ012)