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GMDN’s adoption of the standards set by the J5 and the K7
Following decades of hard work and support by Myotronics to substantiate the scientific and clinical efficacy of the J5 Dental TENS and the K7 Evaluation System, the international agency of GMDN (The Global Medical Device Nomenclature) has selected the J5 and the K7 descriptions as the standards by which the regulatory agencies in 145 countries assess and regulate TMD evaluation and treatment devices. These device descriptions are now accepted and used by regulatory bodies in 145 member countries. This is a major development for the field of NMD, further increasing its global acceptance.
J5 (47555): An assembly of devices designed to apply electrical stimuli to the mastication and facial muscles. It typically consists of an electrical pulse generator, appropriate active electrodes that are usually placed on the coronoid notches of the mandible, and a common return electrode located at the nape of the neck below the hairline. The device is typically used in dentistry to relax the facial and mastication muscles, to treat temporomandibular joint (TMJ) dysfunction and associated pain, to relieve symptoms associated with muscle spasm, to take occlusal registrations and denture impressions, and for other therapeutic measures.
K7 (47556): An assembly of mains electricity (AC-powered) devices designed to record parameters for mandibular and muscles of mastication function, primarily to aid in the diagnosis and treatment of temporomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient evaluation. It typically uses surface electromyography to evaluate muscle groups at rest or in function; sonography to detect sounds/vibrations from the TMJ joint and/or other computer-based system to non-invasively track the mandible in function or identify its position in space relative to the skull.
GMDN’s adoption of the standards set by the J5 and the K7 has significant legal and regulatory implications for TMD treating clinicians around the world.
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