Electrocardiograph, Ambulatory (Without Analysis)

How Is MWJ Classified?

Electrocardiograph, Ambulatory (Without Analysis) is FDA product code MWJ, Class 2, 21 CFR 870.2800.

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 1 clearance under this code; the FDA took 90 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 5 recalls under this product code since 2020. None was by a company in China. The root causes the FDA records most often are Process control (2), Software design (2) and Device Design (1).

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