Controller, Foot, Handpiece and Cord

What Is FDA Product Code EBW?

Controller, Foot, Handpiece And Cord is FDA product code EBW, Class 1, 21 CFR 872.4200.

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. Chinese applicants hold 5 clearances under this code; the FDA took a median of 391 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Process change control (1) and Software Manufacturing/Software Deployment (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.