FDA Grants 510(k) Clearance to NanoVibronix’s Updated Pain Therapy Device

The FDA granted premarket 510(k) clearance to NanoVibronix’s PainShield MD Plus, an ultrasound pain therapy device updated from its predecessor, PainShield MD.

PainShield MD Plus covers twice the treatment area and treats pain and soft tissue injuries directly over joints or orthopedic hardware without the need for ultrasound gels. The updated device is an effective alternative to opioid treatments and can be used at home, the company said.

NanoVibronix also plans on submitting a 510(k) application for PainShield Relief, an over-the-counter device, in the near term.