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- For evaluation of the status of muscles at rest and in function - As an aid in muscle re-education and muscle relaxation therapy - Provides ability to compare new captured data with past data to assess progress in treating patients relaxation state

The device incorporates circuitry enabling the same capabilities as the predecessor device. It is a computer based system offering options capable of evaluating muscle groups at rest or in function by means of surface electromyography. Muscle activity is quantified by means of re-usable or disposable surface electrodes positioned over the muscle groups being studied. Up to eight sites can be monitored simultaneously and displayed in time or frequency domains. The device is essentially identical to the predecessor device except that it utilizes wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage.

As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models 54, JS, and BNS-40.

A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface.

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.

- For evaluation of the status of muscles at rest and in function - As an aid in muscle re-education and muscle relaxation therapy - Provides ability to compare new captured data with past data to assess progress in treating patients relaxation state

The device incorporates circuitry enabling the capabilities of the two predecessor devices to be offered as a single device. It is a computer based system offering options capable of evaluating muscle groups at rest or in function by means of surface electromyography. Muscle activity is quantified by means of re-usable or disposable surface electrodes positioned over the muscle groups being studied. Up to eight sites can be monitored simultaneously and displayed in time or frequency domains.

For Jaw Tracking functions of this device: - Tracks mandibular movement and position . - . For the diagnosis of functionaldisorderssuch as TMJ/MPD syndrome, muscle tension, bruxing, and instability of occlusion - Identification of mandibular rest position . - Identification of interocclusal distance and freeway space . - . Monitors the position of the jaw in three dimensions - Represents the spatial position of the mandibular incisal edge relative to the skull . For electromyographic function of this device: - Intended for use for muscles of mastication, especially temporalis, masseter, and digastric ● - . Designed to perform a limited number of functions in dental diagnosis - For use as a stand alone system for clinical monitoring of up to eight differentmuscles. it is ■ ideally suited for diagnosis and treatment evaluation by recording function of the muscles of the stomatognathic system - The determination of the degree of relaxation of a particular muscle or muscle group at rest . - The precise measurement of relative levels of contraction of several muscles during a ■ functional test For both functions of this device: - Diagnosis and management of TMJ/MPD disorders, orthodontic patients, denture patients, . and reconstruction patients. The addition of the feature described in this new Premarket Notification does not expand upon the above indicated uses.

The Model K6-I Diagnostic System is a surface electromyographic device that measures and records electrical potential emanating from muscle (in addition to its ability to track and document mandibular position/range of motion). The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described above and in the Special 510(k).

For evaluation of the status of muscles at rest and in function. As an aid in muscle re-education and muscle relaxation therapy. Provides ability to compare new captured data with past data to assess progress in treating patient's relaxation state.

The Norodyn: 8000 is a surface electromyographic device that measures and records the electrical potential emanating from muscle. The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described in the Special 510(k).