Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1725](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1725) → EXW — Pill, Radio

# EXW · Pill, Radio

_Gastroenterology, Urology · 21 CFR 876.1725 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXW

## Overview

- **Product Code:** EXW
- **Device Name:** Pill, Radio
- **Regulation:** [21 CFR 876.1725](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1725)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K840934](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXW/K840934.md) | MEDILOG PH1 | Oxford Medilog, Inc. | Jun 28, 1984 | SESE |

## Top Applicants

- Oxford Medilog, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXW](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/EXW)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com