Is the Neubie Device cleared by the FDA?

Yes, the Neubie is FDA-cleared as a Class-2 medical device.

Because it can go up to the maximum power allowed by law, it also requires a prescription or the supervision of a licensed practitioner. 

The Neubie is indicated for:

  • Maintaining or increasing range of motion
  • Increasing local blood circulation
  • Neuromuscular Re-education
  • Preventing atrophy
  • Reducing spasms
  • Preventing venous thrombosis after surgery
  • Management or relief of chronic pain
  • Management of post-surgical and post-traumatic acute pain

It is also contraindicated in patients who have a cardiac pacemaker or are pregnant.

The Neubie is most commonly used in combination with the NeuFit Method, which uses techniques from functional neurology, physical therapy, and other disciplines to maximize the impact of the Neubie and enhance treatment outcomes.