The 3CPM Company, 3CPM Electrogastrogram (EGG) is the first FDA-cleared, patented, non-invasive, diagnostic device that records, stores, displays and prints the myoelectric signals from the stomach as an aid to the diagnosis of potential and known gastric motility disorders. The significant advantage is that, it is only via a stimulatory challenge to the stomach, in this case a water load, that the device is able to uncover and detect motility abnormalities.
This 3CPM Analyzer is intended for use as a diagnostic device that receives records and produces a visual display of the myoelectrical signal produced by the stomach. It is to be used to record an Electrogastrogram, as a component of a comprehensive clinical evaluation in patients with symptoms consistent with known or suspected gastrointestinal motility disorders.
- The Center for Devices and Radiology Health (CDRH) of the Food and Drug Administration completed its review for the classification of the (3CPM) EGG Machine designed by 3CPM on August 20, 1999.
- The 3CPM device is classified as a Class II device with clearance to market as an Electrogastrography (EGG) System under FDA regulations (21 CFR 807) under 510(k) number K984637.