Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Fujian. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Something High Electric (Xiamen) Company Inc. Fujian, contract manufacturer
What Is It?
A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.
What Is FDA Product Code QRC?
Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation is FDA product code QRC, Class 2, 21 CFR 876.5026.
How Does It Reach the US Market?
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.