NAOV - NanoVibronix files for FDA clearance of ultrasound pain therapy device PainShield MD Plus

NanoVibronix (NASDAQ:NAOV) said it submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) seeking clearance of PainShield MD PLUS, an ultrasound pain therapy device. A 510(k) is a premarket submission made to the FDA to show that the device to be marketed is as safe and effective, substantially equivalent, to a legally marketed device. The company said its predicate device PainShield MD had received market clearance in 2008, and was the first Low Level Low Frequency pain device available in the U.S. NanoVibronix (NAOV) noted that PainShield Plus, like the original PainShield, uses ultrasound therapy to treat pain and various soft tissue injuries either directly over joints or orthopedic hardware without the need for ultrasound gels. NAOV +3.93% premarket to $0.69

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NanoVibronix files for FDA clearance of ultrasound pain therapy device PainShield MD Plus