External Mechanical Stimulator for the Relief of Congestion

Who Makes This Device Type in China?

One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.

Yahorng Dongguan Electronic Co Ltd Guangdong, contract manufacturer

What Is It?

The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.

How Is QZC Classified?

External Mechanical Stimulator For The Relief Of Congestion is FDA product code QZC, Class 2, 21 CFR 874.6010.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

External Mechanical Stimulator For The Relief Of Congestion

Sonu (Black Headband)

Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 22 and older.