QQG — Oropharyngeal Electrical Stimulator Class II
FDA product code QQG covers "Oropharyngeal Electrical Stimulator", a Class II medical device regulated under 21 CFR 874.5950. Submissions are reviewed by the Ear, Nose, Throat panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QQG
- Device Class
- Class II
- Regulation Number
- 874.5950
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220025 | phagenesis limited | Phagenyx System | September 16, 2022 |