FDA product code QQG: Oropharyngeal Electrical Stimulator

QQG is the FDA product code for oropharyngeal electrical stimulator. It is a Class II device, regulated under 21 CFR 874.5950 and reviewed by the Ear, Nose and Throat panel. Devices under QQG reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

FieldValue
Device nameOropharyngeal Electrical Stimulator
Device classClass II
Regulation21 CFR 874.5950
Review panelEN — Ear, Nose and Throat
Medical specialtyEar, Nose, Throat
Premarket route510(k)

Recalls for QQG devices

openFDA lists no recalls for product code QQG.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

Frequently asked questions

What is FDA product code QQG?

QQG is the FDA product code for oropharyngeal electrical stimulator. It is a Class II device, regulated under 21 CFR 874.5950 and reviewed by the Ear, Nose and Throat panel.

What device class is QQG?

Class II, regulation 21 CFR 874.5950. Typical premarket route: 510(k).

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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