Device, Counter-Pulsating, External

How Is DRN Classified?

Device, Counter-Pulsating, External is FDA product code DRN, Class 2, 21 CFR 870.5225.

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. Chinese applicants hold 5 clearances under this code; the FDA took a median of 279 days from receipt to decision on them. One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2009. None was by a company in China. The root cause the FDA records most often is Software design (1).

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