Oropharyngeal Electrical Stimulator
The Oropharyngeal Electrical Stimulator is an ear, nose, and throat device that stimulates afferent nerve fibers of the oropharyngeal mucosa to treat swallowing dysfunction (dysphagia), and may incorporate a feeding tube as part of its design. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 874.5950 in the Ear, Nose, Throat specialty. It carries product code QQG and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QQG
- Device Class
- FDA class 2
- Regulation Number
- 874.5950
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220025 | Phagenyx System | Sep 16, 2022 | Unknown | Phagenesis Limited |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.