21 CFR 874.5950 — Oropharyngeal Electrical Stimulator
Ear, Nose, Throat (EN) · Part 874 Subpart F—Therapeutic Devices · § 874.5950
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QQG | Oropharyngeal Electrical Stimulator | 2 | 1 | SaMD |
Special Controls
QQG — Oropharyngeal Electrical Stimulator
In combination with the general controls of the FD&C Act, the oropharyngeal electrical stimulator is subject to the following special controls:
De Novo Order DEN220025
