FDA 510(k) Premarket Clearance for PainShield Plus to treat chronic pain
NanoVibronix, Inc., medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, announced FDA 510(k) clearance of its PainShield MD PLUS, its dual-actuator ultrasound pain therapy device
Brian Murphy, CEO of NanoVibronix, stated, “Securing 510(k) clearance for PainShield Plus is a key milestone towards achieving permanent clearance from the FDA and full-scale commercial marketability. Increasingly, healthcare providers and patients are seeking effective, non-pharmaceutical therapies for the treatment of chronic pain. PainShield Plus expands on the effectiveness of its predecessor, our original PainShield M.D., by covering twice the treatment area and broadening the opportunities for application. As a result, we have started the process of making the recommended modifications to the device in order to comply with the FDA standard. In addition, this approval opens the door for us to submit a 510(k) application for our Over-The-Counter product, PainShield Relief, in the near term.”
PainShield system is a novel, therapeutic ultrasound therapy device for pain treatment. The PainShield portable, wearable ultrasound therapy machine is a battery powered electronic unit that uses an actuator that is applied on the skin at the location of pain and through which it delivers localized energy creating therapeutic effect to relief pain and induce soft tissue healing. This is made possible due to proprietary technology which allows for the creation of a small therapeutic transducer that can be easily used by the patients in the convenience of their own home or in the healthcare facilities.
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