The NXPro is an FDA-cleared, Class II, over-the-counter medical device that can be sold directly to healthy consumers without a prescription. This means any healthy individual (free from designated contraindications) can purchase and use this device on themselves or other health individuals for muscle conditioning, ensuring adequate safety and effectiveness in delivering advanced neuromuscular stimulation.
An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.
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