QQG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Oropharyngeal Electrical Stimulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.5950
- Medical specialty
- Ear, Nose, Throat
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Phagenyx System (DEN220025) | Phagenesis Limited | 2022-09-16 |
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Every clearance here is in the API, with alerts when new ones post.