Stationary Ultrasonic Diathermy Device for Use in Applying Therapeutic Deep Heat

What Is It?

Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.

What Is FDA Product Code PFW?

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat is FDA product code PFW, Class 2, 21 CFR 890.5300.

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. The review can be done by an FDA-accredited third party, which is usually faster. 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.