QQG · Oropharyngeal Electrical Stimulator
Ear, Nose, Throat · 21 CFR 874.5950 · Class 2
Overview
| Product Code | QQG |
|---|---|
| Device Name | Oropharyngeal Electrical Stimulator |
| Regulation | 21 CFR 874.5950 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube. The Phagenyx System is a neurostimulation device delivering electrical stimulation to the oropharynx, to be used in addition to standard dysphagia care, as an aid to improve swallowing in patients with severe dysphagia post stroke.
Classification Rationale
Class II (special controls). The device is granted under De Novo classification as the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the oropharyngeal electrical stimulator is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220025 | Phagenyx System | Phagenesis Limited | Sep 16, 2022 | DENG |
Top Applicants
- Phagenesis Limited — 1 clearance
