(90 days)
To provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To pinpoint muscle activity during movement objectively isolating abnormal movements with abnormal muscle patterns. To establish relative functioning of muscle in any specific anomaly that may occur due to muscle damage, muscle fatigue, hypertonicity or stress. To pinpoint referred pain pattern associated with cervical, thoracic, lumbosacral upper and lower extremities. and refer pain sources. To evaluate a baseline muscle activity for pre-employment screening, sport medicine. To look at chronic vs. acute muscle function and range of motion to ascertain good effort with FCE, range of motion, and gripping, and pinch. To ascertain the ischemic activity of muscles. To ascertain chronic damage to muscles. To monitor the frequency range for cardiac muscle.
The Physical Monitoring Registration Unit, (PMRU) combines up to 48 channels allowing for a minimum of 18 channels of refined surface EMG to monitor any muscle group in the body. This is also beneficial in monitoring the cardiac muscle. This system also features lead status circuitry to integrate correct placement of all EMG electrodes. The additional channels monitor functional capacity sensors range of motion, the J-Mar grip and pinch strength measurement devices.
The provided text does not contain detailed information about acceptance criteria or specific studies demonstrating device performance against such criteria. The document is a 510(k) summary for the Physical Monitoring Registration Unit (PMRU), focusing on its description, intended use, and substantial equivalence to predicate devices, rather than a performance study report.
Therefore, I cannot extract the requested information to fill in the table and answer the subsequent questions. The document confirms that the device was deemed substantially equivalent to existing devices, which is a regulatory hurdle, but does not present the specific performance data one would expect from a study designed to meet acceptance criteria.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).