Electrode, Pacemaker, Temporary

How Is LDF Classified?

Electrode, Pacemaker, Temporary is FDA product code LDF, Class 2, 21 CFR 870.3680.

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. Chinese applicants hold 1 clearance under this code; the FDA took 268 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 15 recalls under this product code since 2008. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Process control (4), Process design (3) and Nonconforming Material/Component (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.