21 CFR 876.1725 — Pill, Radio
Gastroenterology, Urology (GU) · Subpart B—Diagnostic Devices · § 876.1725
Identification
A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EXW | Pill, Radio | 2 | 1 | |
| FES | Recorder, External, Pressure, Amplifier & Transducer | 2 | 2 | 3rd Party |
| FFX | System, Gastrointestinal Motility (Electrical) | 2 | 69 | 3rd Party |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 2 | 31 | 3rd Party |
| NYV | Gastrointestinal Motility System, Capsule | 2 | 4 | SaMD |
