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Used to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, to relax muscles and establish a physiologic occlusion, to take occlusal registrations, to take denture impressions, to increase local blood circulation and to increase or maintain mandibular range of motion.

The device is an ultra-low frequency, battery operated muscle stimulator used to relax the muscles of the head and neck. It is capable of stimulating either two or four muscle groups at once.

This document is a 510(k) premarket notification for the Model J-5 Myo-monitor and does not contain the information required to answer the questions about acceptance criteria and a study proving device performance. The letter states that the device is substantially equivalent to a legally marketed predicate device (Model J-4 Myo-monitor) based on its intended uses and fundamental technology. The substantial equivalence is determined without requiring clinical studies or data that would typically include acceptance criteria or detailed study results.

Therefore, I cannot provide the requested information from the provided text.

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