Classification of J5 Myomonitor Muscle Stimulation/Dental TENS

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J5 Myomonitor is a 510K regulatory Class: II device classified as an ultra-low frequency, battery operated “muscle stimulator” used to relax the muscles of the head and neck. (Yes, you are technically correct as to its not classified as a “TENS machine”, but it is recognized by FDA to be 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.

Many within the dental TMD community recognize and acknowledge “dental” neuromuscular stimulation occurs when a low-amplitude, low frequency, intermittent BILATERAL stimulation that causes muscles to alternately contract and relax in a pumping manner, are applied bilaterally over the coronoid notch, where the stimulus reaches the mandibular region of the trigeminal nerve (V) deep to the mandible as well as the superficial facial (VII) nerve. (This is dental use and application of such a “muscle stimulator” – specific to how one can enhance a more optimal bite registration, a neuromuscular occlusal dental key).

Dixon established the parameters for low frequency TENS
B. Jankelson hypothesized that when a stimulus was placed at the coronoid notch one can stimulate all V and VII nerves and muscles that are effected.

Choi and Mitani document that the stimulus from the Myomonitor is neurally mediated. All muscles of mastication are pulsed by the stimulus and muscle relaxation is verified by sEMG recordings.

Williamson study conducted during oral surgery would stimulate muscles but would give succinylcholine that would block the stimulus – myo-monitor stimulus. Oral surgeon then gave Nyloxone which would reverse reaction thus allowing stimulus to continue, proving and validating that muscle stimulation via the coronoid notch was in fact neurally mediating the neuro-muscular responses via the trigeminal and facial nerves…. thus a transcutaneous electroneural (TENS) response was recognized.

Strictly speaking, the FDA classification of J5 calls it a Dental Electrical Muscle Stimulator. The term Dental TENS has stuck for over 50 years because dentist recognize that the Myomonitor when used in Dentistry via the coronoid notch application as indicated for its dental use is a neural mediated muscle stimulus (producing an involuntary response of all muscles of mastication, thus Dental TENS as specified is capable of stimulating either two or four muscle groups at once bilaterally via Vth and VII nerves.

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Classification of J5 Myomonitor Muscle Stimulation/Dental TENS