Certifications and Awards

 

Certifications and Awards

  • FDA-cleared for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment in the management of post-surgical and post-traumatic pain (available by prescription only).
  • ISO-13485 Certified
  • CE Approved
  • CB Certified
  • Best of Dallas Electromedical Equipment: 2009, 2010, 2011
  • Keeping America Strong Award, presented by Rear Adm. Kevin Delaney (RET): 2006

FDA Clearance

Avazzia BEST-RSI, BEST-PRO 1 and Body-Stim devices and accessories are FDA-cleared as a microcurrent TENS device for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.

Health Canada Clearance

Avazzia BEST devices are cleared in Canada as a microcurrent, biofeedback device for muscle training and re-education, electrical nerve stimulation, improved circulation, improved range of motion and management of chronic pain, intractable pain, post-surgical pain and traumatic pain.

ISO-13485

Avazzia has received the prestigious ISO-13485 Quality Certification for medical products.

CE Mark

Avazzia devices are cleared in Europe as a microcurrent, biofeedback device for muscle training and re-education, electrical nerve stimulation, management of chronic pain, intractable pain, post-surgical pain and traumatic pain.

CB Safety Certificate

Avazzia BEST devices and accessories have been certified to meet safety standards IEC 60601-1, 60601-1-2 for TENS devices.

 

 

 

MKT-130401-11A



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